Isabelle Pinguet

Isabelle Pinguet

Senior Consultant, CMC and Scientific Writing

Key Knowledge Areas:

  • CMC (Chemistry, Manufacturing and Controls)
  • Scientific Writing
  • Pharmaceutical Development

Contact

Education

Isabelle holds a PharmD and a Master degree in “Analyse Chimique, Contrôle du Médicament et Autres Produits de Santé” from the Faculty of Bordeaux, France (2012)

 

About Isabelle

Isabelle is specialized in Technical-Regulatory Affairs and more specifically in CMC (Chemistry, Manufacturing and Controls) 

  • Pharmaceutical development activities : management of operational and strategic activities for the development of products ; coordination of all CMC activities in formulation, analytical development, process scale-up, pre-clinical and clinical supplies (Ph I – II- III), and transfer to CMO.
  • CMC regulatory activities : definition and implementation of CMC regulatory strategy for development projects, scientific advices with Health Authorities, CMC regulatory documents (IND, IMPD, IDE, CTD module 3, NDA, BLA, PMA etc), life cycle management.

Background/Past experience

She started her professional career in 2012 in the Analytical Development department of ARKOPHARMA Laboratories. She was in charge of Analytical Validations, and ensured the implementation of new strategies and innovative statistical tools pertaining to her activity.

In 2013, she joined the Technical-Regulatory Affairs department of ARKOPHARMA Laboratories as R&D Pharmaceutical Specialist. She was in charge of the writing and the maintenance of the Quality sections of MAA dossiers (new registrations, pharmaceutical variations and responses to authorities). She was also involved in the initiation of new R&D projects. Her double expertise in Analytical Chemistry and Regulatory Affairs enables her to ensure consistency between regulatory requirements and practical reality with Quality Control and Analytical Development departments.

Isabelle moved to consultancy and joined BLUE-REG in September 2013.