Regulatory Planning and Due Diligence

We write regulatory plans that align the delivery of regulatory objectives with the overall development plan.

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We produce regulatory plans for products across different modalities (small molecule and biologics plus cell and gene therapies) and therapeutic areas. We will write a coherent and well-thought-out regulatory plan, which will make best use of your resources, reduce delays in your development programme and avoid excessive agency fees.

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Optimise Your Timeline

We can help you align your development timeline with major regulatory milestones through to approval.

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Understand Your Competitors

We research your competitors in late-stage clinical development, which may impact the registration strategy.

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Gain Regulatory Clarity

We will advise you on the scope of mandatory regulatory submissions through to approval.

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Achieve Orphan Registration

We provide recommendations for regulatory and orphan exclusivity.

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Improve Your Paediatric Investigation Plan

We advise and support all aspects of your paediatric investigation plan - structure, strategy and timings.

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Address Gaps

We provide peer review of existing projects, to provide recommendations to address gaps.

The Importance of a Regulatory Plan

It is very common, especially early in development, to be required to deliver multiple regulatory submissions for multiple regulatory agency interactions, including:

  • orphan applications,
  • scientific advice, and
  • the paediatric investigation plan (PIP).

The timing and content of these regulatory deliverables will depend on the timing of your other development activities, including when you plan to submit your marketing authorisation application (MAA). Therefore, preparing and submitting a successful MAA requires a carefully considered regulatory strategy - starting at least 2–3 years in advance.

It is often difficult to prioritise what to focus on first, and how to conduct regulatory agency interactions most efficiently. A clear regulatory plan is invaluable to ensure you adhere to best practices for MAA planning and effectively streamline all your regulatory submissions before you get to MAA filing.

It is always a good idea to write a regulatory plan in Phase 1 and then again at least 2 years before you submit your MAA. The former will help you plan your early-to-mid-phase regulatory interactions, and the latter will make sure you have identified everything needed to file your MAA.

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.

All regulatory milestones in the lead up to your MAA filing

The timing and scope of all the major regulatory milestones through to the submission of the MAA (orphan, scientific advice, PIP, Rapporteur and European Medicines Agency [EMA] meetings). Effective timelines will help you efficiently allocate resources and integrate your development activities.

Evaluation of existing guidance and the prevailing approvals landscape, and analysis of near-term competitors in late-stage clinical development.

  • All of these factors can impact the development strategy and MAA submission.
  • Evaluating these aspects will help you understand where there may be risks to
  • your development plan and how these can be mitigated or avoided.
  • Collecting this information also has an economy of scale regarding designing
  • clinical trials.
  • Accelerated and expedited approval pathways including conditional marketing authorisation, PRIME, ILAP, Breakthrough Designation and Accelerated Assessment.

Subscribe to our Monthly Regulatory Intelligence Scan

Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.

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How Somerville Development Partners can support your regulatory strategy

We have produced regulatory plans for numerous products across different modalities (small molecule and biologics plus cell and gene therapies) and therapeutic areas. We will write a coherent and well-thought-out regulatory plan, which will make best use of your resources, reduce delays in your development programme and avoid excessive agency fees.

We will:

  • 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.

Subscribe to our Monthly Regulatory Intelligence Scan

Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.

Newsletter Optin

You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.

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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

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