Regulatory Affairs Services
Listed below are the main services that Di Renzo Regulatory Affairs is able to offer companies operating within the fields of medicinal products for human and veterinary use, cosmetics, medical devices, biocides, food supplements and medical devices.
- Active Pharmaceutical Ingredient (API): regulatory updates on the importation of raw materials, authorisations and regulatory activities
- Advanced therapies: review the regulatory aspects
- Adverse Drug Reactions (ADRs): gathering information from the National System ofPharmacovigilance (Sistema Nazionale di Farmacovigilanza, SNF), from literature and reports
- Agenzia Italiana del Farmaco (AIFA): relations with the technical and administrative officials of the Italian Drug Agency (AIFA) with regard to regulatory activities for medicinal products for human use
- Agent: regulatory collaboration in taking on the role of agent for medical devices and IVD
- Allergens:assistance with the regulatory activity
- Antifraud optical stickers: application to the Italian State Printing Office (Istituto Poligrafico dello Stato),control and collaboration with the company and the Printing Office
- Artwork: preparation, updates and amendments to graphics
- Audits at companies to verify the pharmacovigilance system, scientific information, quality control, manufacturing of medicinal products, cosmetics, dietary supplements, biocides, medical devices and raw materials
- Authorised representative: assumption of the role of authorised representative for medical devices and IVDs
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- Biocides: assistance withnational and international regulatory activities
- Biosimilars: assistance with regulatory activities
- Broker: requests for acknowledgment of the figure of the broker, introduced by Directive2011/62/EU, amending Directive 2001/83/EC, and regulatory cooperation
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- CE Marking:assistanceforCE markingof medical devices andIVDs
- Centralized procedure(CP)for medicinal products: assistance with regulatory activities
- Certificate of Pharmaceutical Product (CPP): requests to the AIFA, sworn translation, consulate endorsements
- Chemical analysis: contacts with specialized laboratories
- CIOMS: English translation of ADRs in CIOMS format and / or in xml format in accordance with the E2B standards
- Claims: verification of the claims used in the labelling of food supplements and cosmetics, in accordance with current legislation
- Clinical trials for medicines and medical devices: assistance with regulatory activities
- Common Technical Document (CTD): formatting dossier into NTA format, preparation of thenew dossier in CTD format
- Compassionate use of medicinal products: assistance with regulatory activities
- Concession of sale: examination of agreements between companies, preparation of regulatory documentation and procedures at the responsible agencies
- Contract Research Organization (CRO): contacts with several national and international CROsfor clinical trials on medicinal products and medical devices
- Co-promotion: assistance with regulatory activities
- Cosmetics: regulatory assistance, including regulatory aspects concerning the importation of cosmetics
- Cosmetovigilance: management and assistance with regulatory activities
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- Data entry and database management in pharmacovigilance
- Decentralised Procedure (DCP) for medicinal products: assistance with regulatory activities
- Deputy in the field of pharmacovigilance
- Development Safety Update Report (DSUR): assistance with regulatory activities
- Device–vigilance: management and assistance with regulatory activities
- Disinfectants: assistance with all the regulatory stages
- Disposal of waste/stocks: assistance with the information to pharmacists and registration at Farmastampati
- Distributors of medicines and other health products: assistance with regulatory activities
- Drug Master File (DMF): collaboration when applying for authorization for use of an active ingredient in medicines
- Drug Safety
- Due diligence on the dossiers of medicinal products for human and veterinary use, food supplements, Presidi Medico Chirugici (PMC), biocides, medical devices, cosmetics
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- eCTD/NeeS:formatting of old dossiers and preparation of new dossiers in eCTD format or NeeS
- EudraVigilance: Data Entry
- Expert Reports: in the chemical, clinical and pharmaco-toxicological field
- Expertise on legal agreements, acquisitions, transfers and concessions
- Export of cosmetics, dietary supplements, medical devices: regulatory assistance
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- Feasibility: preliminary examination of the classification of a product and assistance with regulatory activities in order to commercialize
- Focused training courses
- Follow up of adverse reactions to drugs and medical devices
- Food supplements: assistance with regulatory activities
- Foodstuffs intended for athletes: assistance with the regulatory activity
- Foodstuffs intended for diabetics: assistance with the regulatory activity
- Foodstuffs intended for special medical purposes: assistance with the regulatory activity
- Free samples: assistance with regulatory activities
- Free Sales Certificate (FSC): request for and legalization of FSCs
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- Gap analysis on dossiers of medicinal products for human and veterinary use, food supplements, Presidi Medico Chirurgici (PMC), biocides, medical devices, cosmetics
- Gluten-free foods: assistance with the regulatory activity
- Good Clinical Practice (GCP): audits, assistance with regulatory activities
- Good Laboratory Practice (GLP): audits, assistance with regulatory activities
- Good Manufacturing Practice (GMP): audits, assistance with regulatory activities
- Graphics: preparation of artwork, booklets, pamphlets, brochures, scientific information materialetc.
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- Health Technology Assessment (HTA): preparation of documentation for medicines and medical devices
- Herbal products: assistance with regulatory activities
- Homeopaths: assistance with regulatory activities
- Hypo / sodium-free foodstuffs: assistance with the regulatory activity
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- Importing cosmetics, dietary supplements, medical devices: regulatory assistance
- Insecticides and insect repellents: assistance with regulatory activities
- Inspections: assistance during inspections and responses to the findings of the AC and NB
- Institutional relations and assistance with regulatory activities
- International regulatory activities (www.drinternational.biz) for medicinal products for human and veterinary use, medical devices, food supplements, cosmetics, Presidi Medico Chirurgici (PMC), biocides
- Internet sites: implementation, verification of accuracy and authorization request
- In Vitro Diagnostics (IVD): assistance with regulatory activities
- ISO 13485: regulatory assistance for implementing the quality system
- ISO 9001: preparation of SOPs and quality system management manuals
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- Labels: preparation, updates and amendments
- Legal & notary public assistance for the preparation and reviewing of agreements for legal representation, sales licensee, marketing transfer of medicinal products
- Legal representative: assumption of this role with the AIFA, Ministry of Health and National Institute of Health (Isituto Superiore di Sanità, ISS)
- Legalization of documents and sworn translations
- Line extensions for medicinal products for human and veterinary use
- Literature: screening of local and worldwide literature (pharmacovigilance)
- Local contact point: taking responsibility as a local contact point for pharmacovigilance
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- Management of Regulatory Affairs for medicinal products for human and veterinary use, food supplements, Presidi Medico Chirurgici (PMC), biocides, medical devices, cosmetics
- Manufacturing plants: regulatory assistance, audits, preparation procedures and quality systems
- Medical evaluation of ADRs
- Medical devices: assistance with regulatory activities
- Medicinal products for human use: assistance with regulatory activities
- Medicinal products for for veterinary use: assistance with regulatory activities
- Ministry of Health: administrative and technical reports for medicinal products for human and veterinary use, biocides, Presidi Medico Chirurgici (PMC), cosmetics, medical devices and food supplements
- Mock-ups: preparation, layout, updates and amendments
- Mutual recognition Procedure (MRP) for medicinal products: assistance with regulatory activities
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- National and international regulatory updates
- National Institute of Health (Istituto Superiore di Sanità): technical and administrative reports
- National Network Pharmacovigilance (Rete Nazionale di Farmacovigilanza, RNF): full management control of the RNF, inserting cases from the literature
- National registration procedure for medicinal products: assistance with regulatory activities
- Notification in the “Repertorio” of Ministry of Health of medical devices marketed in Italy
- Notification to the Ministry of Health of printed material for food supplements & cosmetics
- Notified Bodies (Enti Notificati): contacts and consultancy on obtaining CE marking
- Nutraceuticals: assistance with regulatory activities
- Nutritional Supplements: formulation development and assistance with regulatory activities
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- Official Journal: publishing listings on behalf of companies
- On-line payment (POL): creation of POL for payment of fees to the AIFA and the Ministry of Health
- Orphan Drugs: assistance with regulatory activities
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- Parallel imports: assistance with regulatory activities
- Patents and trademarks: assistance with regulatory activities
- Patient Information Leaflets: preparation of and updates to the texts
- Pay back: collaboration with companies for the calculation of the figures to be paid
- Periodic Safety Update Report (PSUR): preparation of the report
- Pharmacovigilance for medicinal products for human and veterinary use
- Pharmacovigilance System Master File (PSMF): preparation of the report
- Phytovigilance and surveillance for natural substances
- PIL User Testing: preparation of the full readability test, focus testing and bridging reports and final report
- Post-marketing surveillance of medicinal products for human and veterinary use, food supplements, Presidi Medico Chirurgici (PMC), biocides, medical devices, cosmetics
- Preliminary analysis of business projects regarding the regulatory aspects related to medicinal products for human and veterinary use, cosmetics, Presidi Medico Chirurgici (PMC), biocides, food supplements & medical devices
- Presidi Medico Chirugici (PMC): assistance with regulatory activities
- Pricing and reimbursement: dossier preparation, strategic analysis, pharmaco-economic studies, negotiation with the authorities
- Product Information File (PIF): drafting of texts
- Product Information Leaflet (PIL): drafting and translation of leaflets
- Publicity material for medicines, medical devices, Presidi Medico Chirurgici (PMC): verifyaccuracy of materials and request authorization
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- Quality Assurance (QA): assistance with the regulatory activities and acceptance of the role of responsibility
- Quality system: implementation of the quality system (preparation of dossier), assistance during inspections by certification bodies
- QRD: updatingleaflets, labels andSPCs into QRD format
- Qualified Person responsible for Pharmacovigilance (QPPV): assumption of the role
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- Radiopharmaceuticals assistance with regulatory activities
- Raw materials (API): regulatory updates on imports, authorisations, regulatory activities
- Readability test of patient information leaflets for medicines: assistance in the adaptation of the leaflets, full readability test preparation, focus and bridging test reports and final report
- Reimbursement (request) of fees paid to the Ministry of Health, Institute of Health and AIFA
- Regions: request reimbursement of medical devices and other products
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): cooperation with specialized companies
- Registration dossier of medicinal products for human and veterinary use, food supplements, Presisi Medico Chirurgici (PMC), biocides, medical devices, cosmetics: drafting and updating
- Registration of medical devices and IVDs in the Ministry of Health database
- Regulatory activity and marketing authorizations in Italy and beyond for medicinal products forhuman and veterinary use, medical devices, food supplements, cosmetics, Presidi Medico Chirurgici (PMC) and biocides
- Regulatory Compliance
- Regulatory Networks: participation in two international regulatory networks
- Regulatory expertise and interpretations of legislation
- Renewals: preparation of documentation and assistance with regulatory activities
- “Repertorio” of Ministry of Health: notification of medical devices in the database
- Representation of foreign companies, legal representation, review agreements, assistance with regulatory activities
- Responsible person for regulatory affairs, pharmacovigilance, quality, scientific information, production: assumption of the role
- Review of scientific documentation
- Risk Management Plan (RMP): preparation of report
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- Safety Data Exchange Agreement (SDEA): preparation
- Scientific Advice at the AIFA, other European agencies, the European Medicines Agency (EMA)
- Scientific and technical translations
- Scientific Information: assistance with regulatory activities, assumption of the role of responsible person
- Scientific Information ID cards: request from the individual regions
- Seminars and conferences: assistance with regulatory activities
- SIS Code: preparation of the regulatory documentation needed to obtain the SIS Code andmonitoring the technical / bureaucratic procedures at the AIFA
- Standard Operating Procedures (SOPs): preparation
- Start-ups: assistance with regulatory activities
- Summary of Product Characteristics (SmPC): drafting and translation of the Summaries of Product Characteristics
- Sunset clause: exemptions, assistance with regulatory activities
- Switch (from Rx to SOP / OTC, from SOP to OTC)
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- Traceability of Medicines
- Traditional Herbal Medicines: assistance with regulatory activities
- Training in the field of regulatory and veterinary medicinal products for human use, food supplements, Presidi Medico Chiurgici (PMC), biocides, medical devices, cosmetics
- Transfers and assumption of ownership for medicines for human and veterinary use, food supplements, Presidi Medico Chirurgici (PMC), biocides, medical devices, cosmetics: examination of regulatory aspects
- Toxicology: preparation of safety data sheets for medical devices
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- Variations, Type IA and IB (single and grouping): preparation of the documentation andmanagement of the bureaucratic process
- Variations, Type II (single and grouping): preparation of the documentation and management of the bureaucratic process
- Variations to homeopathic medicinal products
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- Web sites: preparation and request for authorization at the Ministry of Health
- Work sharing for variations: preparation of the documentation and management of the bureaucratic process
