Submission plan
An agreed scope, responsibilities and milestones aligned to the application.
Submission planning & delivery
Regulatory submissions
Bring structure to your submission programme, with experienced regulatory input and practical coordination across the contributing teams.
Planning and managing your regulatory submission.
Preparation brings together the product strategy, supporting evidence, dossier content and operational delivery. We help you define the work, coordinate dependencies and keep the regulatory objectives visible throughout the programme.
When we can help
- You are planning a UK, EU or US marketing authorisation application or filing.
- A dossier needs regulatory review and a clearer delivery plan.
- Multiple contributors need a coordinated regulatory workstream.
- You need support with questions and responses during assessment.
What the support can include
The deliverables are agreed around your requirement. A typical scope may include:
Dossier coordination and review
Regulatory input into content, consistency and readiness across the relevant modules.
Application support
Preparation and coordination of the agreed application components and supporting material.
Assessment support
Help to organise authority questions, response responsibilities and follow-up actions.
How we work with you
We establish the product, procedure and current state of the dossier before agreeing a delivery plan. We then coordinate the agreed regulatory work with your internal teams and, where needed, publishing specialists.
Common questions
Can you take over a submission already in progress?
We can review the current status, outstanding work and responsibilities, then agree a realistic handover and scope.
Can you work with our existing writers and publishers?
Yes. We can provide regulatory coordination within your existing delivery team or scope additional specialist support where appropriate.
Which markets should we discuss?
We provide UK, EU and US regulatory support. Tell us your intended markets so we can confirm the relevant expertise and scope for your product.
Let’s move your programme forward.
Start with your regulatory question. We’ll discuss the relevant expertise and a practical scope.