5020, Sec 38 (W) Chandigarh |

INDIVIRTUS HEALTHCARE SERVICES (P) LTD. 5020, Sec 38 (W) Chandigarh | www.indivirtus.com

(An ISO 9001:2015 Certified Company)

Perfect Blend of Quality and Economy

http://www.indivirtus.com/

INDEX (Click on the Area of your Interest)


Company Profile Management Team Executive Team Consortium Business Verticals Benefits of Outsourcing to Indivirtus Awards & Recognitions Global Footprints

Medical Writing Pharmacovigilance

PSUR / PBER Health Hazard Evaluation (HHE) Calculation of ADE / PDE / OEL HACCP

INDEX (Click on the Area of your Interest)


Clinical Trials Pre-Clinical Studies Bio-Equivalence Studies

GxP Services Audit Services Content Writing Qualification & Validation Training Computer System Validation

Formulation Development Analytical Services Contact Us

COMPANY PROFILE

Indian Company with Virtuousness

Indivirtus is a CRO which offers real time cost effective

solutions to healthcare industry. We help the healthcare

professionals and industry to maximize their efficiencies in

its core competencies while helping them grow their

business.


MISSION AND VISION

To be among the top ten globally competent medical and health economics company capable of providing timely and accurate solutions with highest integrity, while also providing a challenging and growth-oriented environment to our team of experts having a great sense of pride and achievement. VI

SIO

N

MIS

SIO

N To facilitate our customers with quality outcomes and financial prudence by creating and nurturing a team of highly competent and innovative professionals and employing state of the art technology, ensuring precise finesse and excellence.

QU

ALI

TY

Committed to ensure world class quality and excellent customer service. We endeavour to achieve this niche position through continuous up gradation and customer satisfaction while operating under an effective quality management system that fulfils needs of our customers with cutting edge technology.

Perfect Blend of Quality and Economy BACK

MANAGEMENT TEAM

Dr. Upendra Jain, M. Pharm, PhD (Chief Executive Officer) 15 years in Pharmaceutical Sales and Marketing, 12 years in Education

Ms. Veena Kanwar, MBA (HR & IT) (Managing Director) 15 Yrs in HR and Admin


EXECUTIVE TEAM

Dr. Rajinder Kumar Jalali

Chief Scientific and Technical Advisor

30+ Years of experience in Pharma Industry and Patients Care

Ex-Global Head Pharmacovigilance And

Head Medical Affairs & Clinical Research Sun Pharmaceutical Ltd.

Mr. Hari Vayas Bansal

Director-GxP & Regulatory Services

25+ Years of experience in Pharma Industry Quality Management with Ranbaxy, Alkem, Panacea Biotec,

Mylan, Zydus Cadila, PT Sanbe Farma (Indonesia) & Unichem

Ex-Head Quality, Sun Pharma

Dr. Ashish Jain

Director-Business Development, Accounts &

Finance 17+ Years of experience in Chartered Accountancy, Marketing and Business

Development


Dr. Rajinder Kumar Jalali Chief Scientific and Technical Advisor

A Clinician and Pharma industry professional with more than 20 years of experience in heading, managing and advising functions of Pharmacovigilance at a global level (including USA, Canada, European Countries, LATAM, Australia, African Countries, Asia Pacific, India), Clinical Research and Development, Medical Writing and Medical Affairs.

PROFESSIONAL EXPERIENCE: Developing and maintaining an efficient global pharmacovigilance system by providing strategic

directions and leadership in pharmacovigilance operations, at global level to cross-cultural teams across different geographies, including North America & European countries.

Managing and leading teams involved in, End-to-End Clinical Trial Operations from site selection to site close outs for Phase I to IV trials, monitoring plans, Clinical Trial Protocols and Reports in compliance with ICH-GCP guidelines.

Leading teams in development of medical rationales, clinical / non-clinical expert reports for EU, Australia / other regulatory agencies and advising on 505(b)2.


Dr. Rajinder Kumar Jalali Chief Scientific and Technical Advisor

POSITIONS HELD: Global Head – Pharmacovigilance and Head Medical Affairs &Clinical Research, Sun

Pharma. Chairman – Saanvi Ethical Research LLP-IEC for conducting clinical trials in India. Governing Council Member – Sun Pharma Science Foundation and Sun Pharma

Community Health Care Society. Member – Quality Panel & Trainings, Pharmacovigilance Commission of India. Adjunct Professor – Centre for Translational & Clinical Research, Jamia Hamdard

University, Delhi Author - Book Chapters in "Pharmaceutical Medicine and Translational Clinical

Research, An Elsevier Publication 2018," covering topics in Pharmacovigilance; Clinical and Post Approval Safety Data Management, ICSR’s, DSUR & PSURs & RMP's.


Mr. Hari Vayas Bansal Director-GxP & Regulatory Services

PROFESSIONAL EXPERIENCE: Mr. Bansal is a Quality & compliance management professional with 25 years of

demonstrated accomplishments in building commercial quality organizations and implementing compliance and quality improvements, with wide experience in Quality Assurance, Quality Control, Microbiology, Training and Development, Vendor Qualification and Manufacturing.

Mr. Bansal has served in Sterile and Non-Sterile Finished formulations, Dry Powder Injections/Ophthalmic/Oral Solid Dosages manufacturing facilities at Senior Managerial positions, responsible for Quality and Compliance in organizations of repute i.e. Sun Pharma, Mylan, Zydus Cadila, Panacea Biotec, Unichem, Alkem, Ranbaxy and PT Sanbe Farma (Indonesia)

He has been instrumental in the implementation of GMP/Quality systems in compliance with guidelines/regulations like Schedule M, ICH Q7, USFDA, MHRA, MCA, TGA, ANVISA, MCC, WHO, 21 CFR Part 210 & 211 etc.


Mr. Hari Vayas Bansal Director-GxP & Regulatory Services

AREAS OF EXPERTISE: Investigation, Risk Assessment and Root Cause Analysis Audit & Compliance Reduction of QMS elements related to Human errors by monitoring Quality Metrics as per

FDA,MHRA guidelines Vendor Qualification FDA remediation activities Third Party Audits, Due Diligence Audits Productivity improvement by streamlining processes through end to end mapping, gap

assessment, trainings and resource availability. Qualification and Validation of Equipment, System, Facility & Utility Computer System Validation & Computer System Assessment Developmental Trainings & Professional Trainings


INDIVIRTUS CONSORTIUM One Stop solution for all Pharmaceutical Needs

Indivirtus consortium is a group of companies, being lead by Indivirtus Healthcare

Services. Idea is to provide one stop solutions to almost all the services required

by any Pharmaceutical Company.

All the consortium partners are carefully chosen to meet the basic mantra of “A

Perfect Blend of Quality and Economy”. The group companies have

accreditations and certifications to meet the regulatory requirements. Therefore,

you can outsource all your requirements to Indivirtus Healthcare and enjoy the

hassle free services.


BUSINESS VERTICALS

Environmental / Toxicological Services (PDE/ADE/OEL Calculations, Genotox evaluation)

Clinical Trials Pharmacovigilance / Drug Safety Health Hazard Evaluation e-CTD/CTD submissions GxP Services (GMP, GLP, CSV, CSA, GDP, ……) HACCP Formulation Development Pre-Clinical Studies Analytical Method Development and Validation Bioequivalence studies


BENEFITS OF OUTSOURCING TO INDIVIRTUS HEALTHCARE

Perfect blend of quality and economy Experienced team of certified toxicologist Experienced teams of authors 100% compliant to regulatory authorities Data security Quick and time bound delivery Support during audits, if required Information on any updates in data/values Preferred choice of sponsors


RECOGNITIONS Recognized

as “A Cost

Effective Healthcare

Service Provider”

by Prime

Insights Rated as “Top 10 Clinical Trials

Service Provider”

by Swift & Lift


RECOGNITIONS


Recognized as “Company of the Year 2020”

By - CEO Insights Certified as ISO 9001:2015

BACK

GLOBAL FOOTPRINTS

INDIA

UAE

UNITED STATES

FRANCE

BANGLADESH

UNITED KINGDOM

SRI LANKA


Regulatory Writing

Nonclinical Services

Clinical Services

NON-CLINICAL SERVICES Non-clinical modules of Common Technical Document

(CTD): Non-clinical study reports (Module 4), Non-clinical summaries (Module 2.6) and Non-clinical overviews (Module 2.4).

Determination of Health Based Exposure Limits: Permitted Daily Exposure (PDE), Occupational Exposure Limit (OEL) and Occupational Exposure Band (OEB).

Genotox Evaluation using Derek Nexus and Sarah Nexus OR ToxTree

Toxicological Assessment Reports: Toxicology Profile for Cosmetic ingredients, Cosmetic Product Safety Report (CPSR).

MEDICAL WRITING


Regulatory Writing

Nonclinical Services

Clinical Services

CLINICAL SERVICES Clinical trial documents: Investigator’s Brochure,

Protocol, Informed Consent Form, Case Report Forms, Statistical Analysis Plan, Clinical Study Report etc.

Clinical modules of Common Technical Document (CTD)/Dossier: clinical study reports (Module 5), clinical summaries (Module 2.7) and clinical overviews (Module 2.5).

Clinical Evaluation Reports for Medical Devices

Others: Drug Labelling, Biowaivers, Clinical trial waivers and GAP analysis of dossiers – clinical sections.

MEDICAL WRITING


Most Advanced Database Cloud Based E2b(R2)/(R3) Compliant Automated Literature Module Automated Signal Detection

PHARMACOVIGILANCE

ADR REPORTING SERVICES Individual Case Safety Reports (ICSRs), Literature Review Periodic Reports: Periodic Adverse Drug Experience Report (PADER) Periodic Benefit Risk Evaluation Report (PBRER) Periodic Safety Update Report (PSUR)

Developmental Safety Update Report (DSUR) Annual Safety Reports (ASRs)

SPECIALIZED SERVICES Medical Information Centre Risk management plan


Using Artificial

Intelligence

Risk-Benefit analysis Signal Management

PHARMACOVIGILANCE PROCESS OVERVIEW

ICSR Processing

Receipt and Collection of Individual Safety information (Intake on Day 0)

Individual Safety Information Transmission and ICSR Registration (Book-in)

Data Entry & Case Assessment (DECA) - All the events must be coded using Medical Dictionary for Regulatory Activities (MedDRA)

Medical Review (MR)

Quality Control (QC)

Case distribution to Business Partner (Finalization)

Distribution and Submission to Regulatory Authority


PHARMACOVIGILANCE PROCESS OVERVIEW Need for Scientific & Medical Literature in PV


Scientific & Medical Literature is a ‘Significant’ – Source of Information for monitoring of Medicinal Product in relation to: Safety profile & Risk-Benefit Balance

By detecting New “Safety Signals” OR “Emerging Safety Issues”

……as per GVP Module VI “Management & Reporting of Adverse Events to Medicinal Products”


US FDA EMA

Frequency Not Identified but mostly weekly at least. Weekly

Author’s Attribution Applies as Implicit Or Explicit Applies as Implicit Or Explicit

Reporting Serious / Unexpected only Serious & Non-Serious

Exclusions No such exclusions; All Active Moiety

Exclusions Applies as per GVP Module VI

PHARMACOVIGILANCE PROCESS OVERVIEW Requirements of Literature Screening for US FDA & EMA

BACK

PSUR / PBRER Periodic Safety Update Report (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER)

These are pharmacovigilance documents intended to provide an evaluation of the Risk-Benefit balance of a medicinal product for submission by marketing authorization holders at defined time points during the post-authorization phase. Goal: To summarises any new efficacy and effectiveness information To Summarises relevant new information that may impact the benefit risk profile of the MAH

product Examine whether new safety information is in accord with previous knowledge of the

benefit risk profile

ICH E2C(R1) “PSUR” is replaced by ICH E2C(R2) “PBRER” When a new Product is authorized for marketing, that decision is based on a Benefit-Risk balance. If the benefits are greater than risks, then it is known as Positive Benefit-Risk balance


PSUR's are assessed by Regulatory Authorities and the outcomes can be: Maintenance of MAH (Marketing Authorization Holder)

Potentially Withdrawal or Suspension or Restriction on distribution of MAH’s product Variation in Reference Safety Information (If there is an update in the package leaflet)

IBD (International Birth Date): The date of the first marketing authorisation for a medicinal product granted to the MAH in any

country in the world.

EURD (European Union Reference Dates) list EURD list refers to an excel sheet shared by EMA website explaining the frequency of PBRER's

required for submission of different products. If Benefit-Risk balance of a medicinal product changes, then there is a need for Re-assessment.

Minimizing Risks and optimizing Benefits throughout the life-cycle of an medicinal product will promote and protect Public health and enhance patient safety by avoiding un-necessary risks to patients.

ASSESSMENT OF PSUR/PBRER


Indivirtus offers best quality data services in product recall(s) through delivery of: Health Hazard Evaluation (HHEs) for classifying a voluntary recall by a firm Health Risk Assessments (HRAs) for possible harm from a defective or malfunctioning device

HHE Reports: HHE reports allow the regulatory agency’s physician or committee to characterize the total health risk

of the device/product.

What Indivirtus do: Ensure to deliver best quality reports keeping standards quality bar high with respect to the regulatory

needs (FDA etc.) reflecting the compliant language as per the recall regulations with customer compliance.

Try that our customers receive favourable responses from authorities and recalls are avoided. Help the clients to take best measures to resolve safety issues in the device as per

recommendations of authorities.

HEALTH HAZARD EVALUATION (HHE)


CALCULATION OF HEALTH BASED EXPOSURE LIMITS PERMITTED/Acceptable DAILY EXPOSURE (PDE)/(ADE) & Occupational Exposure Limit (OEL)

EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012) Current: Cleaning is a risk-reducing measure and carry-over limits for cleaning validation studies are widely used in the pharmaceutical industry. A variety of approaches are taken in order to establish these limits and often do not take account of the available pharmacological and toxicological data.

New Approach: Review and evaluation of pharmacological and toxicological data of individual active pharmaceutical ingredients (API) enables determination of science-based threshold levels.

PDE/ADE: Permitted/Acceptable Daily Exposure “A dose that is unlikely to cause an adverse effect if an individual is exposed, by any route, at or below this dose every day over a lifetime”


PDE/ADE CALCULATION

Shared facility guideline Medical products provide a benefits to the intended patient or target animal, however as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk.

Cross contamination DRUG PRODUCT

Product A Cross contamination DRUG PRODUCT

Product B

PDE

RISK

-Patient Population -Target Animal

To be implemented for all medicinal

products in shared manufacturing

facilities


PDE/ADE CALCULATION Information Necessary

Non-Clinical Safety pharmacology, Single dose toxicity, Repeated dose toxicity, Genotoxicity, Carcinogenicity, Reprotoxicity, Sensitization

Clinical Pharmacological effects Dosing regime

Adverse Events - severity / incidence


PDE/ADE CALCULATION Factor Values as per ICH Q3DR1

F1 = A factor to account for extrapolation between species Factor 1 – 12, based on body surface conversion Not all species assessed

F2 = A factor of 10 to account for variability between individuals

F3 = A variable factor to account for toxicity studies of short-term exposure Factor 1, 2, 5, 10 Life-long (rodent/non-rodent) versus study duration: acute, chronic, organogenesis (reprotoxicity)

F4 = A factor that may be applied in cases of severe toxicity Factor 1, 5, 10 Potential subjective assessment of ‘severe’ in studies other than those described in the guideline (i.e.

reprotoxicity) F5 = A variable factor that may be applied if the no-observed-effect- level ‘NOEL’ was not established

Factor 1-10 E.g. NOEL(1)/NOAEL(1-5), LOEL(5-10)/LOAEL(10)



PDE/ADE CALCULATION

EXPERIENCE IN PDE/ADE CALCULATION

Experienced team of toxicologist have been the key to train the bunch of enthusiastic quick learners to produce more than 2800 PDE/OEL in a short period of 2.5 years.

More than 130 sponsors across the globe have shown the confidence in team INDIVIRTUS simply because we offer a Perfect Blend of Quality and Economy.

Many of these sponsors have under gone inspections by various regulating bodies but none of them raised any questions on reports produced by team INDIVIRTUS.


HACCP is an internationally recognized risk-based method of identifying and managing food safety related risk in food/drug supply chain facilities. HACCP presents analysis and controls of Biological, Chemical, Physical, Allergenic and Nutritional Hazards right from Raw Material Procurement to Consumption of the Finished Product.

Therefore, Indivirtus will help you build a structure that withstands uniform requirements of the Codex Alimentarius Commission (CAC) – Established by the World Health Organization.

Indivirtus help you to: Identification of the Critical Points where Product/Drug Safety can be compromised Analysis and Mapping of the CCPs, OPRPs and PRPs across the entire Supply

Chain Providing Control Measures or Check Points to Contain Contamination Hands on Training on implementation of the entire system

HAZARD ANALYSIS CRITICAL CONTROL POINTS (HACCP)


CLIENTS WHO ENCOUNTERED AUDITs

Dr. Reddy’s Lab

Hetero Drugs

Ajanta Pharma

Ahlcon Parentrals (B Brown Group of companies)

Unicure Remedies

Bioplus Labs

Intas Pharmaceuticals

Sentiss Pharma


CLINICAL TRIAL Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions and side effects.

Phase Primary goal Typical number of participants Notes

Phase I Testing of drug on healthy volunteers for safety; involves testing multiple doses

20–100 normal healthy volunteers To check for efficacy and safety

Phase II Testing of drug on patients to assess efficacy and side effects

100–300 patients with specific diseases

determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever

Phase III Testing of drug on patients to assess efficacy, effectiveness and safety

300–3,000 patients with specific diseases

determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect

Phase IV Post marketing surveillance – watching drug use in public

anyone seeking treatment from their physician watch drug's long-term effects


PRE-CLINICAL STUDIES


Incorporated in 2010 by experienced team of scientific professionals, our pre-clinical CRO partner offers an integrated platform to support a diversified customer base.

Growing Company

Fastest Growing Indian Company Excellence Award 2017 by International Achievers Conference

Diversified Customer Base

Mix of Pharmaceutical, Biotech, Medical Device, Pesticide, Herbal and Vaccine producing customers from across the globe.

Integrated Services

Offers a range of Preclinical Toxicology, Pharmacokinetics, Biology, Pathology, Biocompatibility Testing and Regulatory submission, Standard for Exchange of Nonclinical Data (SEND) services.

Best-in-Class Talent

Experienced scientific and management team having worked with global pharmaceutical, biotech and other companies.

Delivery Infrastructure

CPCSEA Approved Facility (1723/PO/RcBiBt/13/CPCSEA) GLP Certified (GLP/C-127/2018). Applied for Local FDA and DSIR certification

Awards

‘Preclinical Research Excellence Award’ in First Global Pharma Summit 2K19’ organized by DocRoSh Global Solutions, 2019 Indian Leadership Award for Industrial Development’ from All India Achievers

Foundation in 2017 to Our CEO and Director

• December - Company incorporated with modest and personal investment . 2010

• Establishment of Animal Research facility and support functions.

2013 • Inspection and approval of Animal Facility by the CPCSEA

2014 • Application for GLP certificate. First foreign client 2015

• Standardization of Toxicity studies and Providing services

2016 • Expansion for breeding, bought own Land

2017 • GLP Pre-inspection, Solar plant

• Received GLP Certificate

2018

2012

2018

• Expand to in-vitro lab Capitalizing on our Strengths, we are

growing with Support and Faith of

clients

Presence in UK, inhalation Facility 2019


PRE-CLINICAL STUDIES Key Milestone Achievements

Acute toxicity Studies (including 6 Pack) Single-Dose Toxicity Study in Rodents Acute Eye Irritation study Acute Dermal Toxicity Acute Skin sensitization study Guinea Pig Maximization study Acute Systemic toxicity study Acute Inhalation toxicity study

Repeated Dose toxicity Studies 7-14-Day Repeat Dose Toxicity Study 28-Day Repeat Dose Toxicity Study 90-Day Repeat Dose Toxicity Study 180-Day Chronic Toxicity Study Repeat Dose Inhalation Studies

Genetic Toxicity Studies Reverse Mutation Assay (Ames Assay) Micronucleus Test (MNT) Chromosomal Aberration Assay

Developmental & Reproductive Toxicology Embryo Foetal Development Study in Rodents and

Rabbits - Dose Range Finding and Definitive studies

Male and Female Fertility Study

Species: Rat, Mice, Rabbit, Guinea Pig, Hamster Species: Pig, Dog (3rd Party Collaboration)

Routes Oral, Intravenous (IV), Intramuscular (IM), Intraperitoneal (IP), Subcutaneous, Intra-nasal, Intra-cameral, Sub-conjunctival, Intra-dermal, Intra-stromal, Ocular, Rectal, Penile, Vaginal, Topical, Cheek pouch


PRE-CLINICAL STUDIES Toxicology Services

In Vitro Cytotoxicity Test (ISO 10993:5) Extract Elution test

Hemocompatibility Studies (ISO 10993:4) In vivo thrombosis In vitro hemolysis (ASTM F756-17) Coagulation and Platelet Complement activation

Skin Sensitization (ISO 10993:10) GPMT Buehler Test

Irritation Studies (ISO 10993:10) Mucosal Irritation (ocular, penile, vaginal, rectal, oral) Skin Irritation / intracutaneous reactivity test

Systemic Toxicity (ISO 10993:11) Acute systemic toxicity Repeated dose (14, 28, 90 day) toxicity studies

Implantation Studies (ISO 10993:6) Sub-cutaneous implantation Intra-muscular implantation Bone implantation

Special Customized studies Sub-acute (28 day) or Sub-chronic (90 day) cum

implantation studies (clinical, gross and histopathology)

Genotoxicity Test (ISO 10993:3, OECD) Gene mutations in bacteria (GL 471) Gene mutations in mammalian cells (GL 476) Clastogenicity in mammalian cells (GL 473) Mouse Micronucleus test in rodents (GL 474 Metaphase analysis in rodent bone marrow (GL

475) Unscheduled DNA synthesis test with

mammalian liver cells (GL 486)


PRE-CLINICAL STUDIES Medical Device Biocompatibility Studies, Leachable/Extractable and Material Testing

Species Rat, Mice, Rabbit, Guinea Pig

Pig, Dog (3rd Party Collaboration)

Routes Oral, intravenous (bolus and infusion), intra-

peritoneal, subcutaneous, intranasal, intramuscular, intra-rectal or intra-ocular

Biological Matrices Blood/plasma/urine/feces; Bile, Cerebrospinal fluid, Various tissues such as brain, lung, heart,

liver, kidney, spleen, skeletal muscle, Ocular tissues like aqueous humor, vitreous

humor, lens, cornea, optic nerve

Single, multiple and cassette dosing of compound(s)

Dose escalation study (dose linearity and range finding)

Tissue distribution study (brain, heart, liver, lung, kidney, Eye etc.)

Rank-ordering compounds/formulations Determination of fundamental PK

parameters (Tmax, Cmax, AUC, clearance, oral bioavailability, volume of distribution, etc.)

Blood brain barrier PK-PD Evaluation


PRE-CLINICAL STUDIES Pharmacokinetic Services

PRE-CLINICAL STUDIES Biology Services

Inflammation and Pain Models Arthritis induction using collagen Colitis induction using DSS or acetic acid Psoriasis-like skin disease Excision wound healing model Osteoarthritis induction Carrageenan induced paw oedema Mechanical, thermal, cold Hyperalgesia - CFA Neuropathic pain using Paclitaxel L-5 & L-6 spinal nerve ligation (SNL) Partial Sciatic Nerve ligation (pSNL)

Antipsychotic Activity Models Novel object recognition test Psychosis and social interaction deficit Disruption of Conditioned Avoidance Response Restoration of pre-pulse inhibition (PPI) Neurobehavioral assays

Metabolic Disorders Models STZ induced Diabetes, Diabetic neuropathy Hypothyroidism in rodents Acute and Chronic kidney diseases

Safety Pharmacology Models Rota rod test and Grip strength test Tail flick test, Hot plate test Noninvasive (tail cuff) BP recording

Osteoporosis Models Ovariectomy induced osteoporosis Thyroxine or Ethanol induced osteoporosis Hypercalcemia using Retinoic acid

Biological Reactivity Test (USP 87 & 88) Acute systemic Toxicity test Intracutaneous reactivity test Implantation test

Pharmacopoeal Testing Pyrogen Test Abnormal toxicity test


To assess expected in-vivo biological equivalence of two proprietary preparations of a drug. If two pharmaceutical products are said to be bioequivalent, then they would be expected to be the same for all intents and purposes. Location – Mumbai, financial capital of India. 15 minutes drive from airport Established in 2008, Total Area Spread: 10500 Sq ft. Sub-divided into Clinical, Bio-analytical, Statistical, Information Technology

and Quality Assurance department. Total Staff Strength – 60 [excluding contractual staff] Proficiency: Bioequivalence and Bioavailability studies Registered with CDSCO


BIO-EQUIVALANCE STUDY

42-bed ward with 2-bed ICU

Up-to-date critical care instrumentation and medical inventory, MAC 2000 ECG machines with online data capture of 12-lead ECG.

Self-owned ambulance

Tie-up with Super-specialty hospital [7-10 minutes drive]

Triple access-controlled drug store with humidity chamber, LAF and refrigerator

Dining room, pantry and change room separated from ward

Phlebotomy and sample separation room adjacent to ward thereby restricting movements

Dedicated counseling area for ICF presentation with audiovisual recording.

In-house blank plasma collection for research purpose.


BIO-EQUIVALANCE STUDY Facilities

LC-MS/MS – can detect up to sub-pico gram [LLOQ]

Sample organizer for high, uninterrupted throughput

SDMS software for online data capture and back-up

> 160 [and counting] bioanalytical method databank

Access-controlled sample storage room with 6 deep freezers [-70°C and -30°C]

Eurotherm Data logger for constant online temperature recording of freezers/ refrigerators

Sodium vapor lamps for light-sensitive drugs

Eurotherm data logger for continuous recording of temperature

Robust back-up system through UPS [60 KV] and Genset [250 KV]


BIO-EQUIVALANCE STUDY Instrumentation and Storage Facility

Experienced biostatisticians having faced regulatory audits of FDA, EMA & WHO

All the data processed using SAS software [SAS 9.4]

Conversant with SDTM and aDAM requirements of FDA

Conformation to ICH E-9 guidelines for clinical studies

Independent QA department reporting to management

Robust training program backed with assessment for GCP/ GLP compliance

Managing Data integrity – Paper and electronic data.

All activities ensure compliance to SOP, protocol

Reports generated are in accordance with ICH E-3 guidelines

eCTD compliant scanning of entire BE dossier [Module 5] with FDA/ EMA specifications.



Central Drug Standard Control Organization [CDSCO] – India Medicines Control Council [MCC] – South Africa Medicines and Healthcare products Regulatory Agency – UK Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel

und Medizinprodukte, BfArM) – Germany United States Food and Drug Administration – US European Medical Agency – European Union (EU) Therapeutic Goods Administration – Australia World Health Organization – Geneva Pharmaceutical Inspection Cooperation Scheme (PIC/s)





BA/BE studies in male and female volunteers involving fasted, fed, multiple dose [steady-state] design

BA/BE studies in male and female volunteers of other route of administration than oral [Topical / Sublingual / ODT / Injectable]

Drug interaction studies Dose proportionality/ Dose linearity studies Proof-of-concept studies for generic drugs BA Studies on dermatological products Relative bioavailability studies Bioanalytical method development and validation technology End-to-end management of Phase II, III and IV clinical trials Protocol, ICF, CRF preparation for clinical trials/ BE studies Regulatory and bio-statistical assistance Module 2.4, 2.5, 2.6 and 2.7 SDTM and aDAM compliant data modules



Good Manufacturing Practice (GMP)

Good Clinical Practice (GCP)

Good Documentation Practice (GDP)

Good Laboratory Practice (GLP)

Good Warehousing Practice (GWP)

Good Distribution Practice (GDP)

Good Automated Manufacturing Practices (GAMP)

GxP SERVICES


We provides Auditing Services as per ICH-Q7, WHO-GMP, USFDA (21 CFR), MHRA, EU-GMP & PIC'S Regulatory Requirements.

GAP Assessment & Due Diligence Audits Vendor Assessment and Vendor Management Raw Material (KSMs, Intermediates and APIs) Vendor Audits and Supplier Audits Finished Formulations Vendor Audits, Supplier Audits and Market Authorization Audits Packing Materials Vendor Audits and Supplier Audits Internal Audits and Social Audits Third Party / Loan Licence / P2P Manufacturing Audits Pre- and Post- Regulatory Audit Investigation Audit (Deviation, Market Complaint, OOS, OOT, Etc.) Surveillance Audit Mock Audit

GxP SERVICES GMP Auditing Services


Preparation of Site Master File (SMF)

Preparation of Validation Master Plan (VMP)

SOP’s Writing

QMS & Data Integrity Policy Writing

Preparation of Validation / Qualification Protocol & Reports

Development & Preparation of Training Material

Preparation Of Trends

Preparation of PowerPoint Presentation

Preparation of HR / Admin Polices

Many More....!!

GxP SERVICES cGMP Content Writing Services For Pharma / Healthcare / Biotech / Lifesciences Industry


Preparation of Scientific & Effective Protocol as per Current Regulatory Requirements

Training on Protocol & Performance of Activity Planning of Validation / Qualification Activity Effective Execution of Validation / Qualification activity Effective & Scientific Report Writing, Trend Preparation and Summary Report, We provides above services for:

And All Validation / Qualification services for your Utility, Equipments, Instruments, Micro Lab. Area, Facility, Process etc.

GxP SERVICES Validation / Re-Validation / Qualification / Re-Qualification & Periodic Verification


Computerized Systems Validation Water System Qualification Air Compressor Qualification Process Validation Shipping / Transport Validation Media Fil

Computer System Assessment HVAC System Qualification Area Qualification Clean Room Qualification Cleaning Validation Temperature Mapping

BACK

GxP SERVICES On-Site / Off-Site cGMP Training

Professional Trainings Internal Auditor

Quality Management System

Effectiveness of Trainer

Quality Risk Assessment,

Computer System Validation

Supplier Management System

HVAC System

Water System

Good Documentation Practice

Developmental Trainings Effective Communication

Technical Report Writing

Train the Trainer

Conflict Management

Leadership Skills

Stress Management

Quality Culture


Includes the Commissioning and Qualification of equipment/computer system validation of PLC / HMI / SCADA and preparation of protocols and reports

Includes Data Integrity Forensics and CSV for Laboratory System

The complete Process Includes: Validation Plan Initial Risk Assessment/GxP Assessment User Requirements Specifications and

Functional Specification Risk Assessment Installation Qualification (IQ) Operational/Performance Qualification (OPQ) Traceability Matrix Validation Summary Report

GxP SERVICES Computer System Validation


FORMULATION DEVELOPMENT Research and Development Center

Located in Mumbai, India

Over 10,000 sq. ft. premises State of the Art Facility

Strong Technical Expertise Dedicated to Timelines


Clean Room Partition Dedicated AHUs (HVAC System) Epoxy Flooring

LAF and Pass-box For Dispensing

Ability to Handle Potent Drugs


FORMULATION DEVELOPMENT Research and Development Center

Quality In Design Complex Injectable Formulations Solid Oral Formulation

Liquid / Semisolid Formulations

Product Life Cycle Management

Value Added Nutraceuticals


FORMULATION DEVELOPMENT Our Developmental Capabilities

Modified Release Formulations

Delayed Release Formulations

Oral Disintegrating Formulation

Multi Unit Particulate Systems (MUPS) Nutraceutical Formulations Solubility / Bioavailability

Enhancement

Injectable Formulations


FORMULATION DEVELOPMENT Our Technical Capabilities

Formulation Development In Process Quality Control Analytical Development

Dispensing Booth Tap Density Tester Micro Balances

High Shear Mixer (Multi Capacity) Moisture analyser Sonicator

Universal Blender (Multi Capacity) Particle Size Analyser Centrifuge

Multi Mill ( Dry and Wet Milling) Tablet Friability Tester Water System (Type 1 and 2)

Fluidized Bed Dryer and Processor Tablet Disintegration Tester Tablet Dissolution Tester (Auto Sampler)

D Tooling Compression Machine Tablet Hardness Tester UV Visible Spectrophotometer (21 CFR)

Tablet Auto Coater pH Meter HPLC with PDA Detector ( 21 CFR)

Autoclave Water System HPLC with UV Detector ( 21 CFR)

Magnetic Stirrer Hot Air Oven (25°C-300 °C) Karl Fisher Analyser ( 21 CFR)

High Speed homogenizer Stability Chambers with 40°C/75%RH; 30°C/75%RH; 25°C/60%RH; 2°C-8°C (with 24x7 Back up and 21 CFR complying Software)


FORMULATION DEVELOPMENT Major Equipments, Machines & Set-up

More Than 15+ Patent Application Applied Globally including granted patents Stabilized prolonged release pharmaceutical composition comprising atypical

antipsychotic Multiple unit particulate system comprising Metoprolol Succinate Vilazodone tablets with improved dissolution Topical Aceclofenac formulation Extended release composition of Acetazolamide Pharmaceutical composition of Cannabinoid receptor antagonist Extended release pharmaceutical composition containing Metoprolol Succinate Modified release formulation of Rimonabant Taste masked composition containing Asenapine Maleate


FORMULATION DEVELOPMENT Granted Patents Applications

More Than 15+ Patent Application Applied Globally including granted patents Solubility enhancement of Boswellia

Serrata using melt technology Curcumin formulation using hot melt

extrusion technology Pharmaceutical composition comprising

Dapagliflozin Curcuminoid compositions Platform technology for drying and taste

masking Platform technology


FORMULATION DEVELOPMENT Granted Patents Applications


FORMULATION DEVELOPMENT List of Products Developed- Updated List as on Oct 2020

Product RLD Used

For Product Development

Development Status

Pilot BE

Scale Up

Pivotal BE

Technology Transfer Remark

Open Market Available for Out Licensing

USA EU China Australia South East Asia

Other

Ranitidine Capsules (150 mg, 300 mg) Zentac Done BCS III

Waiver Done Done Done Done

Famotidine Tablets (10 mg, 20 mg) Gaster Done Done Done Done Done Filed with

NMPA

Nimodipine Tablets (30 mg) Nimotop Done Done Done Done Done Filed with

NMPA

Dexamethasone Acetate Tablets (0.5 mg, 0.75 mg) Dectanyl Done Done Done Done Done Filed with

NMPA

Isosorbite Mononitrate Sustained Release Tablets (60 mg) Imdur Done Oct

2020 Done Dec 2020

Nov 2020

Ready for BE

Atorvastatin Calcium Trihydarte Tablets (10, 20, 40 mg) Lipitor Done TBD TBD TBD TBD Ready for

TT

Hydroxychloroquine Sulphate Tablets (200 mg) Plaquenil Done NA Done Done Done ANDA

Approved

Sugammadex Injection 100 mg/ml (2m and 5 ml) Bradion Done NA Done NA Done

EB Stability Initiated

Ongoing

Exclusivity for mentioned Region

Stage Completed

Open for Out-Licensing



Product RLD Used


Development Status

Pilot BE

Scale Up

Pivotal BE




Other

Melatonin Prolonong Released Tablets (2 mg) Circardin Done NA Oct

2020 Nov 2020

Oct 2020

AMV Ongoing

Chlorpromazine Hydrochloride Tablets (10 mg, 25 mg, 50 mg, 100 mg, 200 mg)

USL Done Done Done Ongoing Done Pivotal

BE Ongoing

Pregabalin Capsules (25, 50, 75, 100, 150, 200, 225, & 300 mg)

Lyrica Done BCS I Waiver

Dec 2020

BCS I Waiver

Dec 2020

Ready for TT

Linezolid Tablets (600 mg) Zyvox Done NA Dec

2020 Nov 2020

Dec 2020

Ready for TT

Olmesartan + HCTZ Tablets (20/12.5, 40/12.5, 40/25 mg)

Benicar HCT

Ongoing Nov 2020

Nov 2020

Dec 2020

Feb 2021 Ongoing

Metformin ER Tablets (500 and 1000 mg) Glumetza Done Oct

2020 Nov 2020

Dec 2020

Feb 2021

Ready for TT

Mesalamine DR Tablets (1.2 gm) Lialda Done Oct 2020

Nov 2020

Dec 2020

Feb 2021

Ready for Scale Up

Ongoing


Stage Completed




Product RLD Used


Development Status

Pilot BE

Scale Up

Pivotal BE




Other

Mesalamine Extended Release Pellets (90 and 96%)

Pentasa Sachets

Done NA Oct 2020 NA Jan

2021 Ready for

TT

Mesalamine Extended Release Capsules (250 and 500 mg)

Pentasa Capsules

Ongoing Nov 2020

Jan 2021

Feb 2021

Apr 2021 Ongoing

Ibuprofen and Famotidine Tablets (800+ 26.6 mg) Duexis Ongoing Nov

2020 Mar 2021

Apr 2021

Jun 2021 Ongoing

Bisacodyl Enteric Coated Tablets (5 mg)

Dulcolax DR Tablets

Ongoing Oct 2020

Nov 2020

Dec 2020

Feb 2021 Ongoing

Nefidipine Extended Release Tablets (30mg) Adalat GITS Ongoing Nov

2020 Jan

2021 Feb 2021

Feb 2021

Material Awaited

Artemether + Lumefantine (20+120 mg and 80+480 mg) Riamet Ongoing Nov

2020 Jan

2021 Jan

2021 Jan

2021 Ongoing

Prochlorprrazine Maleate Tablets (5 mg and 10 mg) Procomp Ongoing Nov

2020 Jan

2021 Jan

2021 Jan

2021 Ongoing

Ongoing


Stage Completed




Product RLD Used


Development Status

Pilot BE

Scale Up

Pivotal BE




Other

Cysteamine Bitartarate Delayed Release Capsule (25 mg and 75 mg)

Procysbi Ongoing Mar 2021

April 2021

May 2021

Jul 2021 Ongoing

Abiraterone Acetate Tablets 500 mg Zytiga Ongoing Nov 2020

Jan 2021

Jan 2021

Jan 2021 Ongoing

Fluvoxamine Maleate ER Capsules (100 mg and 200 mg)

Luvox CR Capsules Ongoing Dec

2020 Dec 2020

Feb 2021

Feb 2021 Ongoing

Propranolol Hydrochloride ER Capsules (60 mg ,80 mg,120 mg and 160 mg

INDERAL LA Ongoing Nov 2020

Jan 2021

Jan 2021

Jan 2021

Ready for Scale up

Aprepitant Capsules (40 mg, 80 mg and 125 mg) EMEND Ongoing Mar

2021 Apr

2021 May 2021

Jul 2021

Venlafaxin ER Tablets (37.5 mg,75 mg,150 mg and 225 mg)

Effexor Ongoing Mar 2021

Apr 2021

May 2021

Jul 2021

Metformin Extended Release + Dapagliflozin Tablets (2.5/1000, 5/500, 5/1000, 10/500, 10/1000 mg)

XIGDUO XR Ongoing Mar 2021

Apr 2021

May 2021

Jul 2021

Ongoing


Stage Completed


BACK

ANALYTICAL SERVICES Introduction & Salient Features


Located in Suburbs of Mumbai, at a distance of about 20 km from Airport

Dedicated to testing of Pharmaceutical Products for Regulated Markets

(USFDA, MHRA, TGA, WHO…)

Highly experienced Technical staff with rich experience into Regulatory

markets.

Process of implementation of Electronic Laboratory Notebooks (ELNB) under

progress for data management.

ANALYTICAL SERVICES Objectives


To provide efficient and accurate quality services to our customers.

To impart appropriate training to enhance our employee's competency.

To reduce sample handing and processing time to ensure prompt and on

time analytical results.

To receive feedback from customers and address grievances efficiently.

To enhance customer satisfaction and to reduce customer complaints.

ANALYTICAL SERVICES Capabilities


Analytical Method Development

Analytical Method Validation

Biowaiver studies

Process Validation

Stability Study

Residual solvents

Impurity Characterization &

Profile

Dissolution Profile

Tablets, Capsules (Hard & Soft gel)

Oral Liquids

Ointments, Gels & Creams

Topical Powders

Liquid/Dry powder Injectables

Lyophilized Injections

Other items such as APIs,

Excipients and other formulation

& additives

F O R

ANALYTICAL SERVICES Infrastructure


Instrument Name Make Model No. Of Instrument

LCMS/MS Shimadzu LCMS-8045 1

HPLC (UV/PDA) & UPLC Waters Alliance e2695 5 & 1

GC-HS (FID) Agilent 7890B/7697A 1

Dissolution Tester Electrolab EDT-14LX 4

FTIR Jasco FT/IR-4600 1

UV Spectrophotometer Shimadzu UV1800 1

Walk-in Stability chambers (Total Capacity: 1,00,000L) Newtronics NLWH555SU 5 (ICDAS Software)

Auto-titrator Metrohm 907 titrando 1

Ultra micro analytical balance Mettler Toledo XPE26 1

Semi-Ultra micro analytical balance Radwag XA210.4Y.A 1

Water purification system Milli Q & Adrona Q-Front 2

Glassware cleaning machine Lancer 820 LX 1

ANALYTICAL SERVICES Accreditations


ANALYTICAL SERVICES Glimpses








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CONTACT US


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