Regulatory Strategy

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:

What our clients say about us.

Read more in our Regulatory Affairs downloads.