PHARMACEUTICAL
Audits
- Gap analysis
- Due diligence
Registration activities
- Définition of status of the product (drug, Medical Device, cosmetics,...)
- Définition of the registration strategy
- Writing of MA applications (Modules 1 to 5) in European (DCP, MRP, CP) or national procedures
- Application files outside UE
- SmPC preparation, patient information leaflet, labeling
- Realization of readability tests
- Writing the Environmental Risk Assessment (ERA)
- Drafting of the Risk Management Plan (RMP)
- Risk Analysis Writing for Elemental Impurities (ICH Q3D)
- Risk Analysis for Nitrosamines writing
- CEP file writing and Active Substance Master File (ASMF)
- eCTD formatting (baseline) and publishing
- Electronic submission on behalf of clients (CESP portals, Web Client)
- Follow-up of procedures and exchanges with the health authorities
- on behalf of our customers (handling of MA)
- as a contact person authorized by our clients
Regulatory maintenance activities
- Administrative Variations, Quality, Non Clinical and Clinical
- Requests for changes to information (DMI)
- Extension of therapeutic indications
- MA renewal
- Determination of the positioning of variations
- Submission strategy (grouping, worksharing)
- Request for exemption (sunset clause waiver)
- File application for non-prescription OTC medicines or free access products
- File application for exemption from list of poisonous substances
- Handling and transfer of MA, change of marketing company (“Exploitant”)
Experience special drugs
- Herbal products
- Medical gases
Pharmaceutical Development
