A.R.C. Pharma, based in Neuilly-sur-Seine near Paris, is a leading European consulting firm specialised in Regulatory Affairs for the pharmaceutical, biotech, and healthcare industries. It is an independent and privately-owned subsidiary of the BIOFIDES Group (President and founder Alain Peyrot).
The Company has built and benefits from a strategic network of specialists and experts and has regular links with national agencies in Europe and the EMA. A.R.C. Pharma can also benefit of complementary services in terms of CMC development, formulation development support, analytical development, stability studies… from its CRO partner CEBIPHAR.
Known for their broad expertise, substantial experience, and strong client relationship, our consultants and experts confidentially advise over 250 clients each year, ranging from start-up biotech firms to large global pharmaceutical companies.
- More than 30 years servicing the pharmaceutical industry
- Highly experienced and qualified consultants
- Permanent regulatory watch and comprehensive regulatory database
- Broad network of european experts
- Over 250 clients in the world, including 25 out of the top 30 global pharmaceutical companies
- More than 750 e-Newsletters issued each year
- Over 8,000 participants to our seminars to date
- A.R.C. Pharma is the French official consultancy of the international Cortellis database
- Technical and regulatory advice for health products and pharmaceutical sites
- Optimisation of product development and lifecycle management
- MA submission strategy
- Medical and economic evaluation
- Liaison with experts and Health Authorities
- Regulatory due diligence and writing of dossiers : MA, IMPD, Orphan drug designation, TAU, Self-medication, CE marking, pharmaceutical sites
- Readability testing of patient information leaflets
- Reimbursement and pricing dossiers
- Control advertising
- Submission and follow-up with Health Authorities
- Regulatory Intelligence
- Regulatory e-Newsletters (Infomail A.R.C.™ and InfoDoc A.R.C.™)
- Tailored monitoring solutions
- Seminars and training courses
- Licensing and acquisitions
At A.R.C. Pharma, we are committed to delivering the highest quality tailored service, at the best cost and timelines. We are proud to achieve this goal thanks to the close relationship we implemented with our clients for many years, based on transparency, mutual respect and the guarantee of a total confidentiality.
A.R.C. Pharma benefits from the French Tax Credit accreditation (Ministry of Higher education and Research) and from the SME status - Small and Medium sized Enterprises (European Medicines Agency).