Pre-MAA Regulatory Activities & Strategy

Build a solid, strategic foundation for your submission with expert guidance from day one.

Why Early-Stage Regulatory Strategy is Critical

In drug development, the decisions you make before your MAA submission have the greatest impact. A strong early-stage strategy saves invaluable time, reduces costs, and prevents the clinical holds or rejections that can arise from a misaligned development plan.

Our Pre-MAA services are designed to de-risk your project, align your development with agency expectations, and leverage all available expedited pathways..

Our Pre-MAA Services

We perform a comprehensive review of your non-clinical, clinical, and CMC data. We identify potential gaps, roadblocks, and opportunities, then build a clear regulatory roadmap outlining the optimal path to submission in the UK, EU, and Africa.

De-risk your development by engaging with authorities early. We manage the complete process of obtaining Scientific Advice from the EMA (and national agencies) or the MHRA, ensuring your pivotal trial protocols are aligned with regulatory expectations.

Navigating EU and UK paediatric requirements is a complex, mandatory step. We manage the preparation and submission of your PIP, including strategic advice on waiver and deferral requests, to ensure compliance without delaying your adult program.

Gaining ODD status is a key commercial and regulatory milestone. We compile and submit your ODD applications, skillfully articulating the medical plausibility, significant benefit, and prevalence data required for a successful designation.

Accelerate your timeline. We have the expertise to prepare and submit compelling applications for the EMA’s PRIME scheme and the MHRA’s ILAP (Innovative Licensing and Access Pathway), highlighting your product’s potential to meet an unmet medical need.

Expertise Across Your Key Markets

United Kingdom

Deep expertise in all MHRA regulatory processes, including post-Brexit guidance, ILAP, and national submission requirements.

European Union

Navigating the complexities of the EMA centralised procedure (CP), as well as national procedures (DCP, MRP) with competent authorities.

Africa

Specialist knowledge of key African agencies, including NAFDAC (Nigeria), SAHPRA (South Africa), and Kenya’s Pharmacy & Poisons Board.

Ready to Build Your Regulatory Roadmap?

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