regulatory affairs

Triveritas has extensive expertise in regulatory affairs and product registration; with success across a wide range of pharmaceutical products and vaccines in all animal species, by all application routes.

The regulatory environment is complex.  Our experts understand the needs of the regulatory authorities and also the client’s perspective on the product and know what is possible within the regulations.  We can help you anticipate likely points of contention and assist your plan to address these and minimise the risk of failure before you submit your dossier.

  • strategic advice
  • expert reports
  • regulatory document preparation
  • gap analysis
  • due diligence
  • applications for clinical studies or MRLs
  • production transfer
  • post-marketing support
  • pharmacovigilance
  • Minor Use Minor Species issues
  • training
  • liaison and negotiation with regulatory authorities