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
• Feasibility studies for business projects
• 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
• Feasibility studies for business projects
• 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
• Feasibility studies for business projects
• 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
• Feasibility studies for business projects
• 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)
• Feasibility studies for business projects
• 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
Tel.: +39 06 77209020
Fax: +39 06 70474067
Skype:
di.renzo.regulatory.affairs
twitter: @drregulatory
Milan
Piazza Luigi di Savoia, 24
20124 Milano
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
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