- Technico-regulatory audits and expertises of Health Care Products (Drugs, MD, Cosmetics, Food Add.)
- Strategy of MAA with the Competent Health Authorities (ANSM, EMA, FDA) and preparation of meetings for scientific advises.
- Assessment of MAA in the eCTD format for drugs (national, decentralized and centralized procedures, mutual recognition procedure : MRP)
- Assessment of Temporary Authorization of Use (TAU) : nominative and/or cohort (TAU)
- Assessment of CE marking files of devices.
- Assessment of Product Information File (PIF) and Safety Assessment (SA) for cosmetic products.
- Review of packaging data
- Regulatory Review
- Assesments of application of authorization of pharmaceutical establishment with the status of Exploitant