Cyrille Drouot

QA-CMC Consultant @ INITS

About

Competencies : Regulatory Affairs: - API and CMC section : DMF and CEP Europe and US; registration of new API, submission and questions/answers from US, EDQM and national authorities - Process,IPC, Control Strategy, Starting Material, PGI issues, stability (ICH) - Management of Starting Material project: Chinese Sources (Audit on site) and collaborative projects - Process and analytical Development: Management of process and Dev. Team (R&D) for Production support. Quality : Management and System improvements for cGMP compliance ICH Q7 to Q10,Q11and ISO 13485:2016. QbD strategy and training. Scientific support for investigations, and position papers writing International Audits: ISO 13485:2016 / ANVISA inspection for Medical Device/ IS0 9001 : 2015

Country

France

City

Aix-en-Provence

Industry

Pharmaceuticals

Skill

Secteur pharmaceutique, BPF, Affaires réglementaires, Validation, R&D, Recherche médicamenteuse, Chimie, Chimie analytique, Dispositif médical, Développement de médicament

Experience

QA-CMC Consultant

INITS

2025-7 - Present · 1 yr 3 mos

Montpellier, Occitanie, France

S.Q.A. Senior auditor (Quality cGMP/ISO)

SQA US

2017-1 - Present · 9 yrs 9 mos

Région de Aix-En-Provence, France

CMC Director

Advicenne

2022-3 - 2025-6 · 3 yrs 4 mos

Ville de Paris, Île-de-France, France

CMC Quality Director

Genoscience Pharma

2017-6 - 2022-2 · 4 yrs 9 mos

Région de Marseille, France

(1) New Chemical Entity Development for Hepatocarcinoma - Drug Substance & Drug Product (2) ISO 13485 - Medical Device Class III

Quality Manager

Graftys

2015-9 - 2017-6 · 1 yr 10 mos

Région de Aix-En-Provence, France

ISO 13485 - Medical Device class III - Directive 93/42/CEE Audits - Amélioration continue - Revue de Direction ISO 11137 Sterilization of medical device

Quality and Regulatory Affairs Director

MINAKEM

2011-8 - 2015-8 · 4 yrs 1 mo

Beuvry/Dunkerque/Leuna

Analytical Sciences manager

Nicox

2007-9 - 2010-12 · 3 yrs 4 mos

Chemistry Coordinator NicOx

Nicox

2007-9 - 2008-7 · 11 mos

Analytical science support on Drug Substance development Regulatory documentation preparation Supervision of analytical sub-contractors Supervision of internal analytical work

CMC Manager

Trophos

2003-9 - 2007-7 · 3 yrs 11 mos

TROPHOS Pharmaceutical development: negotiation and management of industrial contracts - Chemical scale up (up to 100kg scale) - Analytical method development and validation - Regulatory documentation: IMPD phase II - Galenic development - Management of the Analytical lab. (1 engineer, 2 technicians

Discovery Chemistry Manager

Trophos

1999-9 - 2003-9 · 4 yrs 1 mo

TROPHOS - In charge of chemical libraries purchasing (45 000 compounds) - Outsourced contract service management (medicinal chemistry programs) - Analytical Laboratory Manager - Team management (recruitment; 2PhD, 2 technicians) - Scientific watch (combinatorial chemistry, drug discovery, competitors