Services

We can offer a wide range of UK and EU regulatory affairs consulting and training services to clients.  IPA has earned the reputation of a ‘can-do-attitude’ to deliver high quality, fast and efficient services including life cycle management and divestment.

IPA regulatory offers help in the situations listed in the following:

  • Assistance with UK and EU MAA procedures.
  • Dossier reviews along with gap analysis.
  • Life cycle management & renewals
  • Manufacturers & Importers Authorisation’s
  • PIL user testing.
  • BREXIT/ Windsor Framework guidance and support

Post Marketing Regulatory Affairs Support

  • Complete management of the National, Mutual Recognition Centralised, and Decentralised procedures. This involves the preparation of an initial MA application that will go through a complete post-approval variation and support.
  • Regulatory strategy and support
  • Training

Regulatory due diligence, Product introductions and investments

To enhance the opportunities for product acquisition and potential licensing opportunities, we can help guide the Regulatory Due Diligence.

At the end of a product life cycle we can help with divestments, sunset clause extension or licence cancellation.