Di Renzo Regulatory Affairs

Di Renzo Regulatory Affairs

In 1985, Di Renzo Regulatory Affairs began its regulatory consulting for medicines for human and

veterinary use, food and dietary supplements, PMC, biocides, medical devices, IVDs, cosmetics

and a range of other related services. As a result of the development of national and international

standards, ever increasing business needs, and thanks to the technical-scientific and administrative

structure which Di Renzo Regulatory Affairs has adopted, more and more companies are entrusting

Di Renzo Regulatory Affairs with numerous activities that were previously performed internally. Di

Renzo Regulatory Affairs collaborates with an international network of regulatory agencies and

consulting firms in all countries of the European Union and the main non-European countries.

• Regulatory Affairs

o Medicinal products for human use

o Medicinal products for veterinary use

o Food supplements, dietary products and

novel foods

o Cosmetics

o Medical devices and IVDs

o Presidi Medico Chirurigici (PMC) and

Biocides

• Vigilance

o Pharmacovigilance:

- Medicinal products for human use

- Medicinal products for veterinary use

o Vigilance and surveillance for medical

devices

o Cosmetovigilance

• Scientific information and advertising

• Clinical trials

• Quality Services

• Audits

• Training courses

• Trademarks and patents

• Legal and notary services

• Translations

• Publications in the

Italian Official Journal

Areas of interest

REGULATORY AFFAIRS

Medicinal products for human use

• Feasibility studies for business projects

• Update on national and international regulations

• Due diligence, gap analysis and preparation of chemical, clinical and pharmaco – toxicological

expertise

• Preparation of applications for marketing authorizations for national, Mutual Recognition,

Decentralized and Centralized procedures initiating from either Italy or another European

country

• Preparation of dossiers in CTD, eCTD & NeeS

• Preparation of variations, extensions, transfers of ownership and marketing authorization renewals

• Drafting, examination and translation of Summaries of Product Characteristics (SmPCs), labels

and leaflets in accordance with current regulations

• Readability Test for the Patient Information Leaflet (PIL)

• Preparation of artworks for immediate and secondary packaging

• Assistance with the traceability of medicinal products and for the application of optical antifraud

stickers

• Consultancy and preparation of price dossiers, Health Technology Assessment (HTA) and pricing

negotiations

• Request for Free Sale Certificates (FSC) and

other documents required for export and their

relevant legalization

• Advice on parallel imports

• Technical and administrative regulatory

consultancy for homeopathic products

• Advice on new applications, variations and

authorization renewals for the production of

active substances or finished products

• Requests for GMP certificates

• Assistance in obtaining authorization for the

storage of medicines

• Assistance in the procedures related to

narcotic drugs and drug precursors

Medicinal products for veterinary use


• Regulatory updates

• Preparation of applications for marketing authorizations for national and European procedures

• Preparation of variations, extensions, transfers of ownership and marketing authorization renewals

• Due diligence, gap analysis and preparation of chemical, clinical and pharmaco–toxicological

expertise

• Translation and update of Summaries of Product Characteristics (SmPCs), labels and leaflets in

accordance with current regulations

• Preparation of artworks for immediate and secondary packaging

• Request for GMP certificates, Free Sale Certificates (FSC) and other

documents required for export and the relevant legalization

• Consultancy on new applications, renewals and

variations of authorizations for the production of active

substances or finished products

• Revision of labels and the composition of animal feed

for veterinary use in accordance with current

legislation

Food supplements for human use, dietary

products and novel foods


• Formulation of new products and/or reformulation of products already on the market

• Preparation of the scientific rationale for supplements containing herbal preparations

(botanicals)

• Conformity assessment of labelling, composition and claims

• Assistance on nutritional and health claims for foodstuffs in

accordance with the EU Regulation 1924/2006

• Development of artworks for the packaging material

• Notification procedure with the Italian Ministry of Health

• Assistance in the notification

procedures for the commercialization

in most European countries and in

certain countries outside the EU

• Request for Free Sale Certificates

(FSC) and other documents required

for export and the relevant

legalization


• Consultancy for manufacturers of cosmetic products in order to comply with the new provisions

of Regulation (EC) no. 1223/2009

• Review and integration of the technical and administrative documentation provided by the

company

• Preparation of data sheets on the toxicological characteristics of cosmetic ingredients

• Preparation and signature of the safety assessment of cosmetic products

• Preparation of the Product Information File (PIF)

• Supervisory service for companies holding a PIF prepared in accordance with non-EU law

• Entering data into the European Cosmetic Products Notification Portal (CPNP)

• Verification of the documents accompanying the import of

cosmetics such as certificates of analysis, batch records, lists of

ingredients

• Evaluation of suppliers and audits by technicians at manufacturing

companies

• Request for Free Sale Certificates (FSC) and the relevant legalization

• Preparation of artworks for cosmetic packaging

Cosmetics


• Advice on Italian and European regulations in

force and regulations in certain other non-EU

countries

• Verification of compliance of technical

documentation and the requirements for the

registration of products and manufacturers in

Italy, Europe and in certain other non-EU

countries

• Notification of medical devices (MDs) and

IVDs in the Repertorio of the Italian Ministry of

Health and in the relevant databases of other

countries belonging to the EEA

• Registration of manufacturers of customized

medical devices

• Preparation of technical files for CE marking

• Contacts with the Notified Bodies and

consultations for obtaining the CE marking

• Contacts with qualified laboratories to

conduct tests on products

• Assumption of the role of Quality Assurance

(QA) as defined by the forthcoming European

Regulation on medical devices

• Assumption of the role of Authorized

Representative

• Regulatory activities related to the import/

export of medical devices (MDs) and IVDs

• Verification of compliance of the

documentation accompanying medical

devices for the customs authorities and

assistance with obtaining health and safety

clearance (Nulla Osta Sanitario) in Italy

• Request for Free Sale Certificates (FSC)and

the relevant legalization

• Verification and assistance with the

authorization of advertisements

Medical devices(MDs) and in vitrodiagnostic medicaldevices (IVDs)


• Information on the Italian legislation on Presidi

Medico Chirurgici (PMC)

• Advice on the regulations in force and on the

evolution of the legislation on biocidal

products, in particular on the transition period

for PMC-biocides

• Verification of the inclusion of the active

substances in the Union list in order to classify

the product as a PMC/biocide/product of free

sale or otherwise, in accordance with current

regulations

• Verification of the requirements for registration

in European countries and in certain non-EU

countries

• Assistance in the preparation and submission

of the registration dossier with the Competent

Authority and the relevant authorization

process for a PMC

• Assistance in the preparation of the dossier for

the manufacturing authorization for PMC and

the relevant authorization procedure with the

Italian Ministry of Health

• Preliminary assessment, preparation and

presentation of the dossier for the

authorization of a biocidal product and

assistance throughout the entire authorization

process

• Identification of studies to be performed

(chemical-physical, toxicological and eco-

toxicological and efficacy studies, etc.) in

accordance with the type of product (PT) of

interest, the active ingredient and the

intended use of the product

Presidi Medico Chirurgici (PMC) and

biocides

• Preparation and verification of PMC and

Biocides labels in compliance with regulatory

requirements

• Request for Free Sale Certificates (FSC) for

PMC and the relevant legalization

• Development of mock-ups of labels and

logos, design and development of brochures,

data sheets and advertising materials

• Preliminary assessment of advertisement

material for PMC and requests for the

appropriate authorization from the Italian

Ministry of Health

VIGILANCE

Pharmacovigilance for medicinal products

for human use

• Assuming the role of the European Qualified Person for Pharmacovigilance (EU-QPPV) –

including the availability of a Backup

• Assuming the role of Local Contact Point for Italy – including the availability of a

Backup

• Daily checks of the Italian National Network of Pharmacovigilance (RNF)

• Periodic training for internal staff of MA Holders on pharmacovigilance procedures

• Periodic pharmacovigilance training for medical sales representatives

• Conducting pharmacovigilance audits

• Periodic verification of Italian and international scientific literature (if applicable), for

medicines and active ingredients

• Medical evaluation of Individual Case Safety Reports (ICSRs)

• Follow-up management

• Data Entry and Quality Control of the ICSR in the safety database (SafetyDrugs®)

• Submission of ICSRs to Competent Authorities (e.g.: inclusion in the Italian National

Pharmacovigilance Network (RNF) and Eudravigilance)

• Safety data exchange with business partners and the English translation of Italian ICSRs in CIOMS

and / or in XML format according to the E2B standard

• Insertion and updates to medicines in the EMA database Extended EudraVigilance Medicinal

Product Dictionary (XEVMPD)

• Preparation of the Periodic Safety Update Report (PSUR)

• Preparation of the Risk Management Plan (RMP)

• Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)

• Drafting, review and updating of safety agreements for the exchange of information (Safety

Data Exchange Agreements - SDEA)

• Periodic review of safety data

• Signal Analysis

• Insertion of the back log of ICSRs in the safety database

Pharmacovigilance for medicinal products

for veterinary use

• Assuming the role of the European Qualified

Person for Pharmacovigilance (EU-QPPV) –

including the availability of a Backup

• Assuming the role of Local Contact Point for

Italy – including the availability of a Backup

• Periodic training for internal staff of MA

Holders regarding pharmacovigilance

procedures

• Conducting audits of pharmacovigilance

• Maintenance of national and international

scientific literature for medicines and active

ingredients

• Management of Suspected Adverse

Reactions (SARs) and inclusion in the safety

database

• Medical evaluation of veterinary medical

SARs

• Follow-up Management

• Submitting SARs to the Competent Authorities

• Safety data exchange with business partners

and translation of Italian SARs into English

• Preparation of the Periodic Safety Update

Report (PSUR)

• Preparation of the Risk Management Plan

(RMP)

• Preparation and maintenance of the Detailed

Description of Pharmacovigilance System

(DDPS)

• Drafting, review and updating of

safety agreements for the

exchange of information (Safety

Data Exchange Agreements - SDEA)

• Periodic review of safety data

• Signal Analysis

Cosmetovigilance

• Assumption of the role of Contact Point for the Italian and European Authorities

• Managing cosmetovigilance and post marketing surveillance in Italy and Europe

• Assumption of the role of responsible person for vigilance or local contact point for Italian and

European Authorities

• Management of incident reports to the Competent Authorities

• Consultancy in the phase of investigation and preparation of corrective actions (FSCA)

• Activities of post marketing surveillance

Vigilance and surveillance for medical

devices

Scientific information and advertising

• Assumption of the role of Responsible for the Scientific Information of medicinal products

• Assistance with the Scientific Information of medicines and submission to the AIFA

• Assistance regarding conferences and congresses

• Assistance on obtaining certification according to Farmindustria guidelines on Scientific

Information

• Evaluation of advertising material to the public related to OTC medicines, PMC, medical devices

& IVDs, authorization requests and authorization procedures

• Development of artwork of brochures and advertising

materials and collaboration in the preparation and

maintenance of websites

Clinical trials

• Regulatory consultancy and assistance for interventional and observational clinical trials

• Review of documentation and technical assistance in the submission to the Competent Authority

and the Ethics Committees

• Data entry into the Italian OsSC and the National Register for Observational Studies

• Translation of the dossier, clinical protocols, informed consent and other documents to be

included in the Clinical Trial Application (CTA)

Quality Services

These consulting activities are aimed at companies and institutions who wish to comply with the

necessary requirements for the achievement of ISO 9001 and ISO 13485, ISO 22716, GXP (GMP, GDP

and GCP).

In this area the following services are provided:

• Preparation of the corporate organization chart

• Preparation of Job Descriptions

• Preparation of the Quality Manual or evaluation of that which is already in use at the client site

• Preparation of Standard Operating Procedures (SOPs) and optimization of management

procedures for all areas of regulatory activity

• Review of technical agreements and execution of audits at suppliers

• Assumption of the role of Quality Assurance

• Contacts with Certification Authorities

• Implementation of the quality system in accordance with ISO standards

Audits

Audit at the following facilities:

• Production sites of active pharmaceutical ingredients (APIs) and finished products, in Italy and in

other European or non-EU countries

• Companies and suppliers of medicines, medical devices, food supplements, PMC, biocides,

cosmetics

• Companies offering services of clinical trials, pharmacovigilance, regulatory affairs

• Warehouses, distributors, wholesalers

Training courses

• Training on fundamental rules and national and European drug registration procedures

regarding the following areas:

o Medicines for human and veterinary use

o Medical devices and IVDs

o Food supplements

o Presidi Medico Chirurgici (PMC) and biocides

o Cosmetics

• The fundamentals of pharmacovigilance

• Organization of internal regulatory activity and relations with outsourced work

• An introduction to Scientific Information and operating obligations

• Enabling of courses for companies in the field of trademarks

and patents

• Introduction to the requirements of the Italian Legislative

Decree 231/2001 and the Code of Ethics

• Fundamentals of Quality Management Systems, including

integrated systems

Trademarks and patents

• Analysis of the corporate project and feasibility study

• Preparation and refinement of documentation necessary for filing and obtaining a

trademark/patent

• Deposit of trademarks and patents at national, Community and international level

• Assistance with the bureaucratic procedure (pre- and post-concession, maintenance)

• Support for any regulatory activity

Publications in the Italian Official Journal

• Electronic publication services for listings in the Official Journal of the Italian Republic acting as

Concessionary of the State Printing Office

Translations

• Scientific translations from/into the following languages: Italian, English,

Portuguese, Greek, Spanish, French, German

• Sworn translations

• Sworn translation into German of leaflets and labels and inclusion in the

Unifarm database (bilingualism) for the Italian market

Legal and notary services

• Legal and Public Notary assistance in the regulatory sector

• Collaboration in the preparation of contracts for the purchase and sale of products

• Elaboration of expertise on legal issues related to regulatory activities

Rome

Viale Manzoni, 59

00185 Roma

[email protected]

Tel.: +39 06 77209020

Fax: +39 06 70474067

Skype:

di.renzo.regulatory.affairs

twitter: @drregulatory

Milan

Piazza Luigi di Savoia, 24

20124 Milano

[email protected]

Tel. e Fax: +39 02 67380552

London

9 Seagrave Road London SW16 1RP

VISIT our

WEBSITEwww.direnzo.biz

D i R e n z o R e g u l a t o r y A f f a i r s

Documents

Di Renzo Regulatory Affairs