Local Contact

Sophie Guillaume

General Manager / Directrice Générale

PharmaLex France
41 rue de Villiers
92200 Neuilly-sur-Seine
France

Key members of our team

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.

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.

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.

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.

Christelle Boileau
Christelle Boileau

Associate Director, Drug Development

Christelle holds a PhD in Pharmacology and brings 20 years of experience in the early development of different types of products (small molecules, biologics, ATMP) in musculoskeletal diseases (osteoarthritis, rheumatoid arthritis), inflammation and aging. She began her career at University of Montreal and pursued in Europe with consulting for biotechs, pharma companies and food industries.

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.

Celine expert France
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).

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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.

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.

Paris

41 rue de Villiers, 92200 Neuilly-sur-Seine

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