Di Renzo Regulatory Affairs ROME - MILAN - LONDON

Transcription

1 Di Renzo Regulatory Affairs ROME - MILAN - LONDON

2 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, 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 us 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.

3 Activities common to all sectors Preliminary examination of company projects related to the regulatory sector Information on the Italian and European and some non-european legislation Preliminary examination of the documentation provided by the client Support and assistance throughout the authorization process with the Italian Medicine Agency (AIFA), Notified Bodies, the Italian Ministry of Health and other European and non-european Agencies Collaboration in the research of laboratories for chemical analysis Sworn translations Scientific translations to/from the following languages: Italian, English, Portuguese, Greek, Spanish, French, German Requests for free sale certificates and other documents necessary for export Assistance in all the processes for start-ups in Italy Legal and notary assistance Collaboration in the preparation of contracts for the purchase and sale of products Professional courses in all areas of our interest Support for and advice on importation/exportation Collaboration in the preparation, update and request for authorization of websites Development of mock-ups, brochures and advertising material Due diligence and gap analysis Registration of trademarks and patents for any type of device or process

4 Medicinal products for human and veterinary use Advice on national and international legislation Preparation of applications for marketing authorizations for National, Mutual Recognition, Decentralized and Centralized procedures initiating from either Italy or another European country Preparation of variations, extensions, transfers of ownership and renewals Drafting, examination and translation of SmPCs, labels and leaflets in accordance with current guidelines Readability Test for the Patient Information Leaflet (PIL) Sworn translation into German of leaflets and labels and insertion into the Unifarm network (bilingualism) for the Italian market Assistance with the traceability of medicinal products and antifraud stickers Assistance with Scientific Information, conferences and congresses Request for GMP certificates, licenses for the import of hazardous substances and samples for clinical trials or other uses Consultation and preparation of pricing dossiers, HTA reports and price negotiation Registration and submission of data into the EudraVigilance database Due diligence, gap analysis and preparation of chemical, clinical and pharmacotoxicological expertise Design and production of artwork for primary and secondary packaging Preparation of dossier in CTD and formatting dossier in ectd or NeeS Advice on applications for authorization for the production of raw materials and finished products Audits at production sites of Active Pharmaceutical Ingredients (APIs) and finished products in Italy and abroad

5 Pharmacovigilance Assuming the role of the European Qualified Person for Pharmacovigilance (EU-QPPV) Assuming the role of Local Contact Point for Italy Validated Pharmacovigilance database Daily checks of the National Network of Pharmacovigilance (RNF) Periodic inspection of national and international scientific literature for medicinal products and active substances Inclusion of cases of Italian literature in the RNF Receiving, processing and medical evaluation of ADRs and reporting in line with current legislation Information requests for follow-ups Translation into English of ADRs in CIOMS format and/or in XML format in accordance with the E2B standard Insertion of ICSRs in EudraVigilance Insertion and update of medicinal products in the European database Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Audits and preparation for inspections by regulatory Authorities Pharmacovigilance Training for pharmaceutical sales representatives and/or company personnel Preparation of Periodic Safety Update Reports (PSURs) Preparation of Standard Operating Procedures (SOPs) Preparation of Risk Management Plans (RMPs) Preparation, maintenance and updating the Pharmacovigilance System Master File (PSMF) Drafting, reviewing and updating Safety Data Exchange Agreements (SDEAs) Data Entry

6 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 OsSC and the National Register for Observational Studies Translation of the dossier, clinical protocols, informed consent and other documents to be included in the CTA Medical devices and in vitro diagnostics Advice on current legislation in Italy, Europe and in certain non-european countries in relation to medical devices Verification of compliance of the technical documentation and the requirements for the registration of medical devices in Italy, Europe and in certain non-european countries Notification of medical devices into the database/repertoire of the Italian Ministry of Health and in the relative databases of other countries belonging to the EEA Agreement zone Notification of in vitro diagnostic devices at the Italian Ministry of Health and other European countries Registration of manufacturers of custom-made devices Preparation of technical dossiers in order to obtain the CE mark

7 Contacts with Notified Bodies and consultancy for obtaining CE marking Contacts with qualified laboratories to conduct tests on devices Gap analysis on the documentation available from companies for marketing authorizations for devices in non-european countries Device-vigilance and post-market surveillance in Italy and Europe Assistance with the submission of clinical trials to the Competent Authorities and Ethics Committees, together with the related consulting activities Assuming the role of QA/RA as defined by the forthcoming European Regulation on medical devices Assuming the role of Authorized Representative Regulatory activities regarding the import/export of medical devices Verification of compliance of the documentation accompanying medical devices for customs authorities and support for obtaining health and safety clearance (Nulla Osta Sanitario) in Italy Audits at companies and suppliers of medical devices Collaboration with and participation in the development of start-up projects in the biomedical field (feasibility studies) Implementation of the quality system in accordance with the ISO Training Courses on European regulations and technical standards Preparation of documents required for Class I devices and technical declarations of compliance issued by Di Renzo Regulatory Affairs Preparation of advertising material and, if necessary, preparation of applications for authorization Request for Free Sale Certificates (Certificati di Libera Vendita, CLV) Preparation of technical reports required for the registration of trademarks and product patents

8 Cosmetics European Central Notification Consultancy for manufacturers of cosmetic products in order to comply with new provisions of Regulation (EC) no. 1223/2009 Preliminary examination of printed material and verification of compliance with applicable regulations Review, revision and possible integration of the documentation provided by the company Preparation and signature of the safety assessment of the cosmetic product Cosmetovigilance Coordination of activities for the preparation of Product Information File (PIF) Verification of documents that accompany imported cosmetics such as certificates of analysis, batch records, lists of ingredients Request for Free Sale Certificates (Certificati di Libera Vendita, CLV) Supplier evaluations and audits conducted by specialized technicians at manufacturing companies to verify the quality and compliance with GMP Preparation of data sheets on the toxicological characteristics of cosmetic ingredients Graphic design for cosmetic packaging Supervision service for those companies who are in possession of a PIF prepared in accordance with regulations outside Europe

9 Particular foodstuffs and supplements Technical support on the conformity of the labelling, composition and claims Compliance with the European Regulation 1924/2006 on the nutritional and health claim indications made for food products Procedure for notification to the Italian Ministry of Health Request for Free Sale Certificates (CLV) Support in the notification procedures and marketing in most European countries and certain non-european countries Assistance in the preparation of chemical analysis by authorized laboratories Formulation of new products and/or reformulation of products already on the market Preparation of the scientific rationale for supplements containing herbal preparations (botanicals) Audits at domestic and foreign manufacturing companies Assistance with the process of phytovigilance Design and development of packaging material

10 Presidi Medico Chirurgici (PMC) and biocidal products Information on the Italian legislation on Presidi Medico Chirurgici (PMC), which include disinfectants and other types of products Advice on Italian and European regulations in force and on the evolution of the legislation on biocides, in particular on the period of transition 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 the Italian and European regulations (feasibility study) Verification of the requirements for the registration in European countries and in some non-eu countries Assistance with the preparation and submission of the registration dossier at the Competent Authorities and relevant authorisation process for a PMC Assistance with the preparation of the dossier for the manufacturing authorisation of the PMC and its authorisation procedure at the Italian Ministry of Health Preliminary evaluation, preparation and submission of a dossier for the authorisation of a biocidal product in accordance with the legislation in force, and assistance throughout the entire authorisation procedure Identification of studies to be performed (chemical and physical analysis, stability studies, toxicological and ecotoxicological studies, efficacy studies, etc.) according to the Product Type (PT) of interest, the active ingredient and the intended use of the product

11 Preparation and verification of labels of PMC and biocides in accordance with current legislation Evaluation of advertisements to the general public relating to PMC and to biocides and the authorisation process for the advertising of PMC Training courses on Italian and European regulations relating to PMC and biocides Request for Certificates of Free Sale (Certificati di Libera Vendita, CLV) for PMC Development of mock-ups of labels and logos, design and development of brochures, leaflets and advertising material Quality service Our consultancy is aimed at companies and institutions who wish to comply with the necessary requirements in order to obtain the ISO 9001, or enhance their workflow and operations, by offering the following services: Drafting of company organisational chart Preparation of Job Descriptions Preparation of the Quality Manual or evaluation of Quality Manuals already in use by the client Optimization of management procedures Drafting of Standard Operating Procedures (SOPs) Review of technical agreements with suppliers and execution of audits at suppliers Assuming the role of Quality Assurance Contacts with certification bodies

12 D i R e n z o R e g u l a t o r y A f f a i r s Rome Viale Manzoni, Roma direnzo@direnzo.it Tel.: Fax: Skype: di.renzo.regulatory.affairs Milan Piazza Luigi di Savoia, Milano direnzo@direnzo.it Tel. e Fax: London 9 Seagrave Road London SW16 1RP VISIT OUR WEBSITE