PharmaLex in France

Our services

As with all of the PharmaLex offices, PharmaLex a.r.c. is offering the entire PharmaLex service portfolio to give our customers the same high standards they are used to – no matter where they are in the world.

Furthermore, PharmaLex a.r.c. can also advise and support our clients will all French specific national requirements:

• Regulatory Affairs:
  • Pharmaceutical establishment (“Etablissement pharmaceutique”) and “Exploitant” status
  • Pharmaceutical responsibility (“Responsabilité pharmaceutique”)
  • Temporary Use Authorizations (“Autorisations Temporaire d’Utilisation”, ATU)
  • Advertising and promotion: review of promotional material and visa dossier
  • OTC: open access dossiers (“dossiers de demande de libre accès”), delisting (“délistage”).
• Anti-gift law: “DMOS” declaration, transparency of links of interest, etc.
• Price & Reimbursement: reimbursement dossiers (new registration, renewal, “SMR” reassessment), “hors T2A” dossiers, “agrément collectivités” dossiers…

Eventually, PharmaLex a.r.c. offers unique services such as regulatory intelligence biweekly newsletters and quarterly seminars, annual consulting subscriptions, as well as training courses (for further information about our training offer, please click here).

Who we are

PharmaLex a.r.c. (Advanced Regulatory Consulting) was established in 2018, from the merger between PharmaLex France and a.r.c. Pharma. PharmaLex a.r.c. is located in Paris (Neuilly-sur-Seine). Our French team operates worldwide while supporting our French customer base on a local level.

PharmaLex a.r.c. has been approved for the Research Tax Credit (2017-2019).

Please contact us at: france@pharmalex.com.

Local Contact