Vorstenbosch Regulatory CMC Support

Over Vorstenbosch Regulatory CMC Support

Bertine Vorstenbosch - de Wijs is an independent Freelance Regulatory Affairs CMC (Chemistry, Manufacturing and Control) Specialist having strong RA CMC experience within the pharmaceutical industry, including knowledge of EU/International regulatory affairs regulations of Drug Substances as well as Drug Products. She can take care of the preparation, review and compilation of CMC (CTD Quality Module 3) regulatory documents and perform all activities (e.g. Change Control) throughout the entire lifecycle of your product, in particular with respect to chemical/pharmaceutical aspects of the Marketing Authorisation Application (i.e. for chemically synthesized 'small molecules' and biological Drug Substances and their formulated Drug Products).

Trefwoorden

• Change Control Requests
• Chemical/Pharmaceutical Writing Skills
• Ctd Quality Module 3 (Drug Substance And Drug Product)
• Regulatory Affairs Cmc (Chemistry, Manufacturing And Control)

Adres

• Hoofdkantoor

  Sint Lambertusweg5291AA GemondeNoord-Brabant, Nederland

Team per functiegebied

Gebaseerd op 1 openbare functieprofielen, stand van 4 september 2026.

• Consulting / Advisory1