Regulatory Strategy through to product launch

  • Scientific Advice Meetings (SAMs) with MHRA and EU agencies
  • Authority liaison
  • Advice on the best submission route for your product in the UK and EU
  • Innovative Licensing and Access Pathway (ILAP)
  • Unfettered Access Procedure (UAP)
  • Project Orbis
  • Access Consortium
  • Marketing Authorisation Applications (MAAs) – dossier preparation and submission
  • Regulatory Agency point of contact throughout the procedure
  • Support with answering questions and negotiating with Agencies
  • Pre-vetting of materials prior to launch
  • Product launch
  • Regulatory strategy
  • Work alongside commercial, marketing and logistics to launch the product
  • Specials
  • Veterinary product licencing and maintenance
  • Fusion Pharma are set up to link to your MHRA Submissions portal to submit on your behalf

Clinical Trials

  • Clinical Trial Applications (CTAs)
  • Substantial amendments
  • Urgent Safety Measures
  • Paediatric Investigation Plans (PIPs)
  • Trial suspension/ termination
  • End of trial submissions

Post-marketing / licence maintenance/ life cycle management (LCM)

  • Gap analyses
  • Artwork / Mock ups creation
  • Variations – strategy, authoring, submission
  • Article 61(3) submissions
  • Chemistry Manufacturing & Control (CMC) variations
  • Safety/ Clinical variations
  • Handling deficiencies/ Requests for Further Information (RFIs)
  • Line extensions
  • Quality Overall Summary (QOS)
  • Periodic Safety Update Reports (PSURs)
  • Post-Approval Commitments
  • Reclassifications e.g. Prescription Only Medicine (POM) to P (Pharmacy) switches and P to General Sales (GSL) switches
  • electronic Common Technical Document (eCTD) publishing
  • NTA to eCTD conversions
  • eCTD Baseline
  • Generic applications
  • Updates to Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and labelling, mock-ups
  • PIL User Testing
  • Company Core Data Sheet (CCDS) gap analysis and alignment
  • Translations
  • Proofing