Your
Bespoke
Regulatory
Consultancy
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
- Fusion Pharma are set up to link to your MHRA Submissions portal to submit on your behalf