REGULATORY AFFAIRS
Audits
- Gap analysis
- Due diligence
Registration activities
- Definition of status of the product (drug, medical device, cosmetics,…)
- Definition 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
- Environmental Risk Assessment (ERA) writing
- Risk Management Plan (RMP) writing
- Risk Analysis for Elemental Impurities (ICH Q3D) writing
- Risk Analysis for Nitrosamines writing
- CEP file and Active Substance Master File (ASMF) writing
- 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
- Management of administrative, Quality, Non Clinical and Clinical Variations
- 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 exemption from list of poisonous substances
- Handling and transfer of MA, change of marketing company (“Exploitant”)
- Regulation related to pharmaceutical and medical devices promotional materials
Experience special drugs
- Drug-Device combination products
- Herbal products
- Medical gases
We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.
Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.
STRATÉGIE SANTÉ
53, Boulevard de la Reine
78000 Versailles - France
Tél : +33 (0)1 42 86 86 00
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