Consulting
Engage with us
You can utilise our wealth of Regulatory Affairs expertise in a way that suits you and your business needs. Engage with us through one-off projects, ongoing consultancy support or by using one of our Regulatory consultants to act as part of your team.
If you require a consultant to act as part of your team for a period of time, it is useful for you to understand that the IR35 UK tax law does not apply, since our consultants are fully employed at Fusion Pharma.
Whilst we specialise in UK Regulatory Affairs, all of our consultants have experience within the EU, we would therefore be able to support any wider project needs.
Our brochure goes into more detail about what we offer.
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
The benefit of working for Fusion is that our consultants are employed by us, which means IR35 is irrelevant (read more here). Another advantage to using Fusion is that you bypass expensive recruitment agency fees!
Consulting / Legacy Page FAQs
Do you support clinical trials, marketing authorisations and lifecycle management?
Yes. Fusion supports clinical trials, marketing authorisations, launch activities and post-approval lifecycle management across a wide range of regulatory work.
Can you support MHRA meetings and authority interactions?
Do you support specialist areas such as Specials, herbals, generics and veterinary medicines?
Yes. Fusion has experience with specialist areas including UK Specials, herbal medicines, generics and veterinary products.
How can companies keep up with changing UK medicines regulation?
Companies can stay current through regular regulatory intelligence, practical interpretation of guidance and support from specialists who understand how changes affect real products and submissions.
What kind of regulatory updates, guidance and practical resources do you provide through your Thought Leadership content?
Fusion’s Thought Leadership content provides practical updates, plain-English summaries, articles, webinars, downloads and resources focused on UK medicines regulation and regulatory practice.