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

  • Sophie Guillaume
    General Manager PharmaLex France 41 rue de Villiers
    92200 Neuilly-sur-Seine
    France
    +33 1 47 59 87 87 france@pharmalex.com

What our clients say about us

We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.

  • PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.

    Top 10 Pharma Company
    President
  • What was especially important to me was their ability to get a team, with the right experience, together so quickly.

    Mid-size Biotech
    Head of Outsourcing
  • Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.

    US Biotech
    Senior QA Associate
  • We couldn’t have asked for a more professional, personable, knowledgeable group of Quality Experts!

    Top 10 Pharma Company, China
    Drug Safety Director