Regulatory Strategy.
What is a regulatory strategy and why is it so important?
Developing a regulatory strategy that considers the many global challenges involved whilst delivering on your objectives is critical to the commercial success of your product.
Planning should start early in development, with continual monitoring of key milestones, data, decision points, regulatory landscapes, with any adaption as necessary, to ensure regulatory success.
Your regulatory strategy will determine the path, cost and time-to-market of your product across multiple geographies, including its label claims and reimbursement, all of which have commercial impacts. Initiatives like EMA’s PRIME, Orphan Designation, Priority Review, Breakthrough Therapy Designation, Accelerated Assessment/Approval and Fast Track designation can provide important regulatory and commercial advantages to sponsors.
These together with the choice of legal basis, approval route (e.g. centralised/versus DCP or MRP in the EU), paediatric requirements, choice of pharmaceutical form and local requirements must be fully evaluated within the regulatory strategy to best mitigate those impacts not just at launch, but over the product’s entire life cycle.
How Arriello can develop and support your regulatory strategy.
From initial MAA/NDA applications through to supplementary/post approval submissions, Arriello’s team of regulatory and subject matter experts will guide and work with your teams to provide an efficient global regulatory strategy for your products.
We provide expertise and solutions with the following functional services:
- Creation/Review of Global Regulatory Strategy Plans, linking clinical development and regulatory steps to approval.
- Assistance with Scientific Advice/Protocol Assistance/Agency Meetings.
- Assistance with Innovation Task Force engagements.
- EMA SME applications and briefing meetings.
- Non-Clinical & Clinical development consulting.
- CMC consulting.
- Review and advice on the suggested legal basis for MAA/NDA submissions.
- EMA Prime Submissions & Accelerated Assessment requests.
- FDA Breakthrough Designation.
- FDA Fast Track Designation.
- ATMP Classification.
- Orphan Drug Designations.
- Paediatric submissions.
- MHRA ILAP.
Selected Regulatory Affairs Case Studies.
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What our clients say about us.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
