• Dutch (Netherlands)
  • French (France)

Regulatory Affairs

Our Belgian Regulatory Affairs office is home to a team of 5 regulatory professionals of various scientific backgrounds (pharmacy; bio-engineering and bio-medical sciences).

Regulatory services offered by the Belgian team include support to international drug development and lifecycle maintenance programs (as part of international project teams), as well as to regulatory projects in the BeNeLux.

Our other services include:

  • Maintenance of existing licenses (variations, renewals, line extensions, supplements etc.)
  • Gap analysis, writing, review and submission of regulatory documents (IB, IMPD, IND, MAA, NDA, sNDA, BLA, Orphan Drug Designation Dossier, Pediatric Investigation Plan, Briefing Documents, Drug Master Files etc.) and support with global Marketing Applications
  • Due diligence; regulatory strategy and advice on global drug development, on registration and post-registration processes
  • Meetings with regulatory agencies globally: briefing package preparation, client rehearsals, meeting attendance at various stages of development
  • Regulatory education, training and process development

Our Global RA is an experienced, dedicated, proactive and diplomatic team of regulatory experts coming from industry and regulatory authorities, with strong capabilities in all areas of regulatory affairs, and decades of experience working with regulatory agencies throughout North- and Latin-America, Eastern and Western Europe, Asia and throughout the world. The team’s experience covers all therapeutic areas and all types of products, including new chemical entities (NCE’s), biological and biotechnological products, vaccines, advanced therapies, GMO’s, biosimilars, generics, etc.

Contact Quintiles