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Regulatory planning and due diligence

We are strong believers in constructing a regulatory plan for your product development. We will look at your clinical data and overall development strategy and create the best path for you to successfully deliver your regulatory objectives, whilst staying aligned to your overall development plan.

We provide a due diligence evaluation of your medicine and advise on the probability of gaining approval – identifying potential regulatory risks in your development plan. We can conduct regulatory due diligence early in clinical development (Phase 1/2), or at a later stage (Phase 2 or 3).

 

How we can help with your regulatory planning

  • evaluate existing guidance and the prevailing approvals landscape,
  • layout development timelines to align with major regulatory milestones through to approval,
  • advise you on the scope of mandatory regulatory submissions through to approval,
  • research your competitors in late-stage clinical development, which may impact the registration strategy,
  • advise and support orphan registration and maintenance strategy,
  • advise and support all aspects of your paediatric investigation plan (structure, strategy, and timings),
  • advise you on the paediatric exclusivity reward,
  • guide and support any scientific advice and protocol assistance,
  • explain opportunities for fee reductions specific to your product,
  • provide recommendations for regulatory and orphan exclusivity, and
  • provide peer review of existing projects, to provide recommendations to address gaps.
Regulatory Plan Resource

Download our free guide

Learn how to construct a well thought out and nuanced regulatory plan, as well as how this project can bring return on investment.

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FAQs

What is due diligence in pharmaceuticals?

Due diligence is the process of evaluating your medicine against regulatory deliverables at pre-specified timelines throughout development.

What is the due diligence process in biotechnology and cell or gene therapies?

The regulatory pathway to approval is similar for biologics, cell and gene therapies and pharmaceuticals. However, there are different aspects of development to consider, including advanced therapy medicinal product classification, the need for additional non-clinical studies, and environmental risk assessments (for genetically modified organisms). Due diligence will help you navigate these regulatory specifications.

Why is due diligence important in medicine development?

A detailed evaluation of your asset’s manufacturing, non-clinical and clinical development programme identifies strengths and weaknesses and—most importantly—the probability of your product being approved.

years of regulatory expertise

clients supported

agency interactions

orphan applications

marketing applications

We have 75 years of regulatory expertise