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

Development Consulting

  • Integrated product development and project management
  • Regulatory and scientific consultancy services
  • Regulatory strategy (incl. health agency interactions), gap analysis and due diligence
  • Scientific, regulatory and medical writing
  • Development CMC, consulting and manufacturing strategy
  • Non-clinical and clinical development services
  • Labeling services
  • Medical affairs & marketing strategy
  • Biostatistics & data management services
  • Pricing & reimbursement services
  • Market access strategy and HEOR
  • Compliance in the relationship with HCP (“Loi anti-cadeau” and transparency)
  • Regulatory review of promotional and non-promotional documents (medicines and MD)

Regulatory Affairs

  • Initial Marketing Authorization
  • Applications, line extensions and referrals in 80+ countries worldwide
  • Full portfolio maintenance service (e.g. variations, renewals) across all regions
  • Global roll-out strategy for new submissions including due diligence activities
  • Consultancy and regulatory operations during M&A activities
  • Change control procedures, CMC writing for chemicals and biologicals
  • Electronic submission services in all formats
  • CCDS development & worldwide roll-out
  • Procedure management and health agency contacts
  • Readability testing

Quality Management & Compliance

  • Develop phase appropriate quality system
  • Gap analysis, remediation and implementation
  • Pre-approval inspection readiness (Mock PAI audit)
  • Warning letter and consent decree remediation
  • External and internal audits
  • Routine compliance support (Document control, CAPA, batch release)
  • EDMS and CSV (21 CFR part 11 compliance)
  • Microbiology and analytical quality control support
  • Supply chain management
  • Product complaint management
  • GMP, GDP and GPvP regulations: interpretations, audit reports
  • Status of “exploitant” established in France

Pharmacovigilance, Epidemiology & Risk Management

  • Pharmacovigilance & Clinical Safety
  • ICSR management, including collection, evaluation, processing, distribution and reporting (incl. validated safety database)
  • Signal management
  • Risk management
  • Periodic safety reports
  • Pharmacovigilance system and compliance
  • EU-QPPV, local QPPV
  • Quality system, audit and inspection support
  • Safety data exchange agreements
  • Pharmacoepidemiology
  • Literature Surveillance (VigiLit)

Our specific services

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.

Subscribe to our e-Newsletters

PharmaLex a.r.c. trainings

Being a training organisation since 1982 with a strong experience in the organisation of topical seminars, a.r.c. Pharma has started since 2016 to propose relevant and qualitative trainings focused on business issues by offering a broad range of intercompany internships. Now called PharmaLex a.r.c. Formations, we continue to accompany all the health industry stakeholders in the assimilation or improvement of knowledge, and in the development of new approaches on technical, regulatory, methodological or organisational aspects.

For that, PharmaLex a.r.c. Formations has built training programs especially around its core business, regulatory affairs, but also in other related topics such as pharmacovigilance, clinical trials or quality assurance.

a.r.c. Pharma was granted in 2015 the CPD (Continuous Professional Development) certification allowing its clients healthcare professionals to fulfill their obligations in terms of DPC (this is ongoing for PharmaLex a.r.c).

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.

Local Contact

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

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PharmaLex a.r.c. trainings

Our management team

Patrick Larcier

Senior Director, VDC DCS – PER, France & Belgium

Dr Patrick Larcier has over 30 years of experience in understanding non-clinical, clinical and regulatory development. He is experienced in co-developing products in both EU/US regions, conducting Early Access and Compassionate Use Programs, setting and monitoring pre- and post- market vigilance activities

His main focuses: innovative medicines in oncology, auto-immune disorders, and orphan indications.

Céline Hocquet-Merlin

Director, Head of REG France

Céline Hocquet-Merlin has over 17 years of experience from process development, to CMC, RA or quality. During the past 8 years among us she gained strong experience in consulting activities, expertise in quality guidelines, variations regulations, pharmaceutical dossiers writing, due-diligence for all pharmaceutical forms, technical and GMP-linked questions (CMC compliance).

Mélanie Alhusban
Mélanie Alhusban

Associate Director, CMC, REG Ops

Mélanie Alhusban has over 10 years of experience in pharmaceutical industry. In charge of the CMC and RegOPS (publishing, submission, …) units, she has joined us in October 2017. She has participated, amongst other activities, in managing regulatory projects, has prepared and contributed to write and review regulatory documents but also to expand the existing portfolio.

Paul Bolot
Paul Bolot

Manager, Prom. Material

Paul Bolot has experience in various areas. From regulatory review of promotional/non-promotional materials for different pharmaceutical products to regulatory consultancy, regulatory labelling, project management and readability tests management. He worked previously at Bayer Healthcare Pharmaceuticals and Servier as a Regulatory Affairs intern.

Blandine Bourrinet
Blandine Bourrinet

Director, REG consulting, Training, Tutoring, QMC Representative FR&BE

Blandine Bourrinet is dedicated to pharmaceutical Responsibility and area of ‘exploitant’ in France; she also gives advices on anti-gift law, transparency and certification of sales representative network. She is responsible for internal/external audits and she is the Head of the French training department (Regulatory & PV)

She is a pharmacist who joined us in 2015, after 15 years in pharmaceutical companies and 7 years in a training organization.

audrey finesso
Audrey Finesso

Director, Drug Development

Audrey Finesso provides Drug development (included early stage) and RA strategy for SME, biotech and pharmaceutical companies for EU/US. She has experience with Scientific Advices meetings with European Agencies (EMA, ANSM, BfArM), orphan drug designation in Europe and Type B & C meetings with the FDA

Also, she has a strong experience in diseases with unmet medical needs/innovative products.

Mathilde Gaultier-Renouf
Mathilde Gaultier-Renouf

Senior Manager, Pharmacovigilance

Mathilde Gaultier-Renouf has over 10 years of experience in drug safety in 2 international pharmaceutical industries (MSD Animal Health and Servier). She has a deep understanding of ICSRs processing, drug safety reports writing, interaction with CAs, involvement in CAs inspections, medical and drug safety training and signal detection.

team member
Valentine Monnier

Manager, Reg. Information / Intelligence

Valentine Monnier, our jurist with a master’s degree in RA, has experience in analyzing and evaluating documents from the French & European regulatory bases. She ensures daily regulatory monitoring with a specific focus on our customers and participates in the regulatory consulting activities; she is also responsible for organizing ActuPractice seminars.

Veronique Mougeot
Veronique Mougeot

Director, Pre-clinical & Clinical

Véronique Mougeot, throughout her 27 years within Pharmalex, gathered experience in consulting in RA, medical writings of all types such as clinical/nonclinical expertise, clinical variations, open access dossiers, etc. During her career she gained experience in areas such as writing protocols, preparation of MA to regulatory agencies, PK and statistical analysis.

marguerite windsor
Marguerite Windsor

Manager, P&R – Market

Marguerite Windsor provides strategic input for market access and maintenance of medicines, MD and food supplements, with a focus on innovative products. She also manages the pricing and reimbursement strategy by coordinating the preparation of the required documentation. Marguerite has been with us for 3 years, she is a jurist with a master’s degree in Health Law and has a PharmD.

sophie guillaume

International Women’s Day

Being in an executive position is an everyday challenge in itself. No difference if you are a woman or a man.

I never considered that being a woman would be a barrier in being part of an executive team. I have been lucky to work with visionary CEOs favouring equal rights between men and women.

Believe in your competencies and question your own practices on a daily basis. Continuously learn from others.

Supporting each other becomes particularly relevant when it comes to work life balance in order to continue developing professionally without sacrificing family life.

carima andrady womens day

International Women’s Day

It’s how we judge each other. We all do it. We must all question pur judgements.  This becomes ever more apparent now we are working remotely more than ever before for some people.

I haven’t faced any major barriers, but I have grown up in a female dominant family always encouraging me to work hard for the things I want in life.

It depends on what stage they are in their careers. As a general advice to anyone who likes science, I would say that your career does not start and end at the bench (lab). The pharma industry has lots of different roles to offer that does not involve constant dedication to lab life.

Women should lift each other up in more ways than one. For me it’s all about being a role model to other young women. I have worked in two companies where the Managing Directors were women with families.

Focus on what you enjoy. Be a role model to others. Don’t be afraid to ask. Your career path may not be linear but eliminating the things you don’t like only strengthens that which you do like.

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 needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.

    Med Device company, US
    Senior Regulatory Affairs Director
  • In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.

    PharmaLex Team Thomas
    Thomas Dobmeyer, CEO PharmaLex
    CEO PharmaLex
  • Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected

    Small US Biopharmaceutical Company
    Sr Director Regulatory Affairs CMC
  • They are available when we need to talk to them despite any time zone differentials

    Japan based medium sized company
    Manager