Regulatory Submissions
We provide end-to-end regulatory submission support across the full product lifecycle: from clinical development through to post-approval maintenance.
Our focus is on high-quality, submission-ready deliverables, aligned to current regulatory requirements and agency expectations.
What we support
Clinical trials
- Clinical Trial Applications (CTAs)
- CTA modifications and Urgent Safety Measures (USMs)
- Paediatric Investigation Plans (PIPs)
- Trial halt, termination and end-of-trial submissions
Marketing authorisation applications
- Dossier preparation and submission management
- Agency liaison throughout the procedure
- Responses to questions and positioning support
- PIL user testing
- Environmental Assessment Reports
Product launch
- MIA, batch release and QP/RP support
- Market access interfaces
- Pharmacovigilance and Medical Information
Post-approval and lifecycle management
- Variations: strategy, authoring and submission
- Deficiency and Request for Further Information (RFI) responses
- Line extensions and post-approval commitments
- SmPC, PIL and labelling updates
- CCDS gap analysis and alignment
- Reclassification (e.g. POM to P, P to GSL)
Specialist areas
We have strong expertise in specialist areas including unlicensed to licensed transitions, UK Specials, herbal medicines, generics and veterinary products, providing confident support where regulatory pathways are less straightforward.
- Specials
- Veterinary medicines
- Herbal medicines
- Generic applications
- Well established use applications
A clear, submission-focused approach
We ensure all submissions are:
- Aligned to current regulatory guidance and requirements
- Structured clearly and ready for review
- Supported by consistent documentation and version control
- Delivered with clear communication and defined timelines
Regulatory Submissions FAQs
What regulatory submission services do you provide?
Fusion provides support with clinical trial submissions, MAAs, lifecycle submissions, variations, RFIs, labelling, PIL user testing and specialist regulatory projects.
Do you support submissions across the full product lifecycle, supporting both clinical trial and marketing authorisation submissions?
Yes. Fusion supports submissions from clinical development, Clinical Trial Applications, CTA modifications and related activities, through marketing authorisation applications, launch and post-approval maintenance.
Do you support responses to regulatory questions and RFIs?
Yes. Fusion helps assess questions, define the response strategy, draft high-quality responses and manage the process through to resolution.
Do you act as a point of contact with regulatory agencies?
Yes, where agreed. Fusion can support or manage agency communications and help ensure questions, positions and responses are clear and well coordinated.
Can you support part of a submission or take over an existing project?
Yes. Fusion can support selected sections, provide targeted review, or take over an existing project where additional expertise or momentum is needed.
Can you work alongside out internal regulatory team?
Yes. Fusion can work as an extension of your team, supporting defined workstreams while fitting into your internal processes and timelines.
Do you support specialist areas such as Specials, generics and veterinary medicines?
Yes. Fusion has experience across specialist areas including UK Specials, generics, herbal medicines and veterinary products.
Can you support unlicensed to licensed product transitions?
Yes. Fusion can help assess the pathway, identify evidence gaps, develop the regulatory strategy and support the submission package for transition to a licensed product.