LIFE SCIENCES LABORATORY SERVICES the area of analytical chemistry. SGS LIFE SCIENCES SGS Life Sciences

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  • LIFE INSPIRED, QUALITY DRIVEN

    LIFE SCIENCES

    LABORATORY SERVICES

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    SGS has been offering high quality analytical testing services to the pharmaceutical industry for decades. We perform a wide range of quality control testing services to support drug research, registration and production. Biopharmaceutical companies use many of the same services, SGS delivers customized solutions to accommodate your unique needs. We perform a variety of tests that are client-specific, particularly in the area of analytical chemistry.

    SGS LIFE SCIENCES

    SGS Life Sciences enables the medical and health innovators of the world to deliver life-changing solutions in the quickest, safest and most efficient way, helping improve the lives of many. We provide the highest quality services, reliable expertise and guidance through our network of labs conveniently located around the globe.

    ANALYTICAL DEVELOPMENT & QUALITY CONTROL TESTING

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    OUR GUIDING PRINCIPLES At SGS, we are guided in all that we do by the values of trust, quality, expertise, reliability, global partnership and integrity; these are the bedrock upon which our organization is built. We also believe that while we are in the business of life sciences, our commitment lies equally in life-saving. This mean taking responsibility for our own operations and practices to ensure we are protecting and preserving all life, in its many forms:

    PEOPLE ANIMALS PLANET

    We do not test on weapons or anything that could be used to threaten life.

    As a cruelty-free organization, we do not conduct any tests on animals.

    We are an award-winning leader in sustainability and carbon neutral organization.

    INDUSTRY GROUP LEADER IN DOW JONES SUSTAINABILITY INDEX

    • RobecoSAM Gold Class sustainability award winner 4 years in a row

    • Ecovadis Gold Rating Sustainability Performance 3 years in a row

    • RobecoSAM Industry Mover

    • CDP Climate A List

    • 356+ community projects

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    RELIABLE & ACCURATE RESULTS

    When it comes to the pursuit of developing life-changing solutions, there’s no such thing as one size fits all; our studies are engineered to your unique needs. As a fully accredited, professionally recognized organization, you can rely on us to act as a neutral third party CRO and deliver unbiased results. We guarantee reliable and accurate testing using state-of-the-art facilities, equipment and techniques and offer advanced Early Phase clinical trials:

    • Phase I-IV Clinical Trial Management, Biometrics & Pharmacovigilance

    • Therapeutic area focus: Infectious Diseases, Vaccines, Respiratory

    QUALITY & COMPLIANCE

    Pushing the boundaries of innovation can be challenging. Identifying, analyzing and mitigating compliance risks are essential in developing an effective compliance program. With more than 40 years of experience, SGS is a trusted name with a history of excellence in meeting regulatory compliance and bringing projects to market. We have a reputation for clinical & laboratory quality & operational excellence (Harmonized QMS and Validation & Transfer methods, LIMS, Lean).

    EXPERT GUIDANCE

    Reduce costs and improve profits by bringing your products to market quickly and safely; let our experienced consulting and project management teams develop a market access strategy with specific tools and tactics to plan, implement, and monitor your stakeholder engagement activities while reducing errors and potentially costly mistakes that can delay bringing your product to market.

    PARTNERSHIP & GROWTH

    With a long standing reputation for our integrity, many companies trust SGS as their global drug development partner; our conveniently located network of labs offer an array of integrated services and expertise, providing you with the knowledge, flexibility and ability to scale.

    • Wide-range of laboratories and clinical research infrastructure

    • Size and diverse testing capabilities matching biopharmaceutical and Small molecules needs

    • International network across America, Europe and Asia

    We provide services along the entire drug development pathway. SGS provides integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical, R&D, characterization, biosafety, and quality control testing of small and large molecules, raw material products and containers.

    ABOUT SGS

    SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 95,000 employees, we operate a network of more than 2,400 offices and laboratories around the world.

    WHY TEST WITH SGS LIFE SCIENCES?

    DISEASE

    DISCOVERY

    PRECLINICAL

    CLINICAL

    ROUTINE PRODUCTION

    MARKET

    CURING

    GET TO MARKET QUICKLY, SAFELY & EFFICIENTLY.

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    SCOPE OF LIFE SCIENCE SERVICES

    CLINICAL RESEARCH

    LABORATORY SERVICES

    • Biologics characterization

    • Biosafety

    • Bioanalysis

    • Quality control for small and large molecules

    CLINICAL RESEARCH

    • Clinical Trials (Phase I-IV)

    • Regulatory Consultancy

    • Biometrics

    LABORATORY SERVICES

    PRECLINICAL

    EXPLORATORY DEVELOPMENT

    CONFIRMATORY DEVELOPMENT

    TRADE DISTRIBUTION

    POST- APPROVAL

    ROUTINE PRODUCTION

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    ANALYTICAL SERVICES

    ANALYTICAL CHEMISTRY

    • Assay and Purity (e.g. Chromatography, Titration, Limit Tests)

    • Identity (e.g. Spectroscopy, Chromatography)

    • Dissolution Test (On Line / Off Line)

    • Pharmaceutical Water Analysis (E.g. TOC)

    • Water Content (Loss on Drying, KF Titration)

    • Disintegration

    • Appearance (e.g. Clarity, Opalescence)

    • pH and Conductivity

    • Osmolality, Osmolarity

    • Melting Point, Boiling Point etc.

    • Viscosity, Rheology

    • Uniformity of Mass

    MICROBIOLOGY TESTING

    • Microbial Limits Tests

    • Sterility Testing

    • Microbial Contaminant Identification

    • Preservatives Testing And Microbial Challenges

    • Microbiological Assessment of Antibiotics

    • Bacterial Endotoxins

    • Environmental Monitoring

    • Water Systems Validation

    • Production Facility Qualification

    • Cleaning Validation

    STABILITY TESTING

    • Long Term Stability Studies

    • Short Term, Accelerated Studies

    • Follow-Up Stabilities

    • Photostability Testing

    • All ICH Conditions + Specific Conditions

    • Fully Controlled and Monitored

    • All Systems With 24 H / 7D - Monitoring And Alert System

    • Validated Monitoring System, 21 CFR Part 11 Compliant

    • Back-Up Chambers Available

    • Comprehensive Documentation

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    ANALYTICAL SERVICES

    METHOD DEVELOPMENT & VALIDATION

    • Method Development for Identity, Assay and Purity of Drug Products, APIs and Degradation Products

    • Method Validation According To ICH Guidelines and/or Customer Requirements

    • Verification of Accuracy And Suitability of The Developed Method

    • Development and Validation of Stability Indicating Methods

    • Transfer Lab To Lab Validation

    • Re-Validation

    COMPREHENSIVE DEVELOPMENT- AND VALIDATION REPORTS

    • Container/ Content Interaction

    • Extractables and Leachables

    • Migration Studies

    • Container Testing (Glass, Plastics, Rubber Closure,Etc.)

    • Identification

    • Classification

    • Limit Tests

    • Biological Tests

    • Heavy Metals

    • Physicochemical Tests

    • Water Vapor Permeation

    MEDICAL DEVICE TESTING

    • Determination of Bioburden before Sterilization

    • Sterility Testing According to USP And EP of Products and Biological Indicators

    • Test for Endotoxins

    • Cytotoxicity Testing

    • Hygiene Monitoring for The Qualification and Control Of Production Zones

    • Test for Ethylene Oxide Residues Din En ISO 10993-7

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    BIOLOGIC ANALYTICAL DEVELOPMENT BIOPHARMACEUTICAL TESTING

    • Host Cell Impurity Testing

    • (Residual DNA / Host cell proteins)

    • Cell Line Characterization

    • Cell-Based Assays

    • Biologics Safety Testing – Endotoxin, Virus, Mycoplasma

    • Product Characterization

    • Protein Analysis

    • Disulfide Bridge & Post-Translational Modification Analysis

    • Stability Studies

    BIOANALYSIS SERVICES - LAB TO CLINICAL

    • Mass Spectrometry & Immunoassays Experts

    • Services for Small and Large Molecule Testing in TK, PK and PD

    • Online Clinical Samples Dosing with CPUs

    • Discovery Biomarkers Translated in Clinical Research

    • Immune Function Testing

    • Immunogenicity, Flow Cytometry, Cytokine Multiplexed ELISA

    • Biopharmaceuticals - Cell Characterization

    • Metabolite Profiling and Balance Studies (14C-labelled drug)

    BIOLOGICS SAFETY TESTING

    • Sterility

    • Direct Inoculation (EP 2.6.1)

    • Filtration Method (EP 2.6.1)

    • Alternative Automatised M