Your
Bespoke
Regulatory
Consultancy
CONSULTING
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
- NIMAR
