PharmaLex in France

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 based on a local level.

PharmaLex a.r.c. has been approved for the Research Tax Credit (2020-2022).

Our services

PharmaLex a.r.c. offers the entire PharmaLex service portfolio, giving 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…

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

PharmaLex a.r.c. provides its consulting services, either within the framework of annual contractual subscriptions defining a number of hours of intervention and limited or not to particular fields, or within the framework of customized services.

Our annual subscriptions (“consulting contracts”) offer you great flexibility by allowing you to contact us on any subject, by email or by phone.

Local Contact

Regulatory Intelligence

PharmaLex a.r.c. offers you a regulatory intelligence service organized at a European and French level and covering all health products: medicines, medical devices, cosmetics, food supplements and biocides.

Our consultants carry out in-depth and systematic monitoring of French and European pharmaceutical regulatory news. We share this knowledge with our subscribing clients. Nearly a hundred pharmaceutical companies currently benefit from our service.

e-Newsletters

• Infomail a.r.c.™
  Information emails on the current healthcare regulations are sent to the subscribers twice a week.
• Infodoc a.r.c.™
  A secured gateway to online regulatory information: targeted search and extensive regulatory database with access to all e-Newsletters.

Personalized regulatory watch: Bespoke regulatory watch, adapted to the specific needs of a company, can be carried out on request.

Infodoc a.r.c.™ Login

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Seminars

Every year, PharmaLex a.r.c. seminars are a much-anticipated event as they allow participants to maintain and deepen their knowledge and skills on specific topics and to exchange with experts.

“ActuPratiques” Seminars

• Organization of “ActuPractiques” seminars taking place 1/2 day.
• On annual subscription
• Thematic meetings on topical issues specific to Regulatory Affairs
• Intervention of specialized experts

Our subscribed clients benefit from a practical and technical approach to the topics covered and can interact with the speakers in a privileged manner.

In conversation with… Caroline Pouget