A.R.C. Pharma

Your expert partner for regulatory affairs


A.R.C. Pharma provides tailored technical and regulatory advice, strategic guidance and full regulatory assistance.

These consulting services are offered either on an annual subscription, or on a specific request basis. Regulatory advice is provided in the following areas:


Health products

  • Pre-marketing authorisation issues
    • Active ingredients, excipients, pharmaceutical raw materials and packaging issues
    • Status definition of drugs and “borderline” products: orphan drug designation, pediatric drugs, TAU products…
    • Pediatric investigation plans
    • Clinical trials: qualification, GCP regulation understanding
    • Risk management plans
    • Strategy of registration procedures, choice of procedure (French & European), positioning applications (generic, well-established use, OTC…), eligibility under the centralised procedure, requirements of authorities
  • Post-marketing authorisation issues
    • Pricing and reimbursement positioning strategy
    • Distribution and marketing issues
    • Advertising issues
    • Pharmacovigilance: interpretation of regulation, qualification
  • Audit of dossiers
    • Administrative and regulatory status
    • Review of modules 2,3,4 & 5
    • Reimbursement status
  • CE mark certification for medical devices

Pharmaceutical sites

  • Drug establishment registration: procedure, dossier preparation, regulatory proofreading, preparation of audit, writing of SOPs, management of changes
  • GMP, GDP and GPvP regulations : interpretation, audit reports
  • Pharmaceutical liability: practice and legal risk, qualified person, import / export issues, distribution issues
  • Code of Ethics for health professionals
  • Preparation for inspections
  • Links of interest

Product development and registration

  • Pharmaceutical development: raw materials or chemicals of biological origin, impurities, genotoxicity, choice of excipient
  • Strategy of registration: choice of procedure, positioning applications (generic, well-established, records abstracts)
  • Validation of orphan drug status
  • Audit of MA dossiers: administrative and regulatory, pharmaceutical, preclinical and clinical
  • Audit records and economic transparency: registration, renewal, modification

In partnership with Cebiphar, A.R.C. Pharma can offer global CMC development consulting services including formulation support and analytical development.

Liaison with the health authorities

We hold numerous and regular consultation meetings with regulators and monitoring procedures for:

  • registration and granting of marketing authorisation,
  • reimbursement, accreditation communities, requests for quotations

Share this page on…

Haut de page