Alain Duguet expert analyste consultant formateur

Support in Analytical Development

With 30 years of experience in Pharmaceutical Industry, in Research and Development as well as in Industrial Operations, I propose assisting you in any activity related to these areas, from implementation of an Analytical Development Programme to the Expertise of Registration Dossiers.

Analytical Development

  • Evaluation at a time of Development: internal or external data (development partner, licensed product)
  • Definition of an Analytical Development programme down to Registration: development and validation of analytical methods, setting up of specifications, tracking of impurities, stability studies, etc...
  • Update of Dossier for an already registered product: improvement of existing analytical methods, revision of specifications, compliance with new regulatory guidance (ICH or others)
  • Managing of seminar to define objectives for analytical development
  • Having already monitored these different activities along my professional career, I can provide you with a background and overview based son concrete experience, allowing you to focus on key aspects of your Development, and avoiding loss of time and resources with unneeded elements.

    A finetuned evaluation of any request for expertise can be discussed with you.

    For more information, see page Contact.