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

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

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



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 

  • All PharmaLex France employees had to adapt to this new situation and learn to work and communicate from home. For our team members who already usually work from home, the adaptation was easy, but for the others, it was necessary to get used to this new way of working and communicating.We also organized “virtual cafés”, to maintain the social link and informal exchanges that are part of company life and team cohesion.
  • PharmaLex ensured complete continuity of its services, by implementing working from home (WFH) for all employees. Health measures, in line with official guidelines, were also implemented on the premises to ensure the safety of employees working on site.In addition, we have developed an internal tool to monitor and make available to all employees all news and new information relating to the COVID-19 epidemic, in terms of regulatory impacts.
  • In France, we ensured our daily monitoring and the sending of our circulars twice a week to our subscribers, with a focus on news related to COVID-19. We also participated in the development of an international newsletter on COVID-19, sent once a week to all PharmaLex customers.

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.

  • We couldn’t have asked for a more professional, personable, knowledgeable group of Quality Experts!

    Top 10 Pharma Company, China
    Drug Safety Director
  • 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
  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited