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REGULATORY AFFAIRS

Regulatory Affairs

We offer full life cycle management activities as either one-off projects through to full portfolio management

Regulatory Strategy through to product launch

 
  • Advice on the best submission route for your product in the UK and EU
  • Marketing Authorisation Applications – dossier preparation and submission
  • Regulatory Agency point of contact throughout the procedure
  • Support with answering questions and negotiating with Agencies
  • Work alongside commercial, marketing and logistics to launch the product
  • Veterinary product licencing and maintenance

Post-marketing / licence maintenance:

 
  • CMC Gap analyses
  • Artwork / Mock ups creation
  • Variations – strategy, authoring, submission
  • Line extensions
  • NTA to eCTD conversions
  • Generic applications
  • Updates to SmPC, Patient Information Leaflets (PIL) and labelling
  • PIL User Testing

Post-marketing / licence maintenance:

 
  • CMC Gap analyses
  • Artwork / Mock ups creation
  • Variations – strategy, authoring, submission
  • Line extensions
  • NTA to eCTD conversions
  • Generic applications
  • Updates to SmPC, Patient Information Leaflets (PIL) and labelling
  • PIL User Testing

Full portfolio management:

 
  • Responsible for all life cycle activities
  • We can involve you as much or as little as you want and always keeping you in the loop
  • Can include Quality and Pharmacovigilance to provide the complete package