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Regulatory Strategy

The decisions that shape a drug development programme are rarely straightforward. Which regulatory pathway to pursue, how to design a pivotal trial that will satisfy agency requirements, whether the available safety data is sufficient to proceed, how to respond to an unexpected finding.

These are questions that require not just knowledge but judgement, and that judgement is only developed through years of direct experience.

At Niche, our consultancy work draws on over 25 years of hands-on involvement in clinical development across a wide range of therapeutic areas.
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"Niche provided invaluable support and their flexibility and ingenuity helped my team overcome many obstacles."
Chaman Chandler
Research Manager
Baxter Healthcare

What We Do

We provide strategic scientific and regulatory advice to biotech and pharmaceutical sponsors at all stages of development. Our consultants are scientists and physicians who have worked in clinical development throughout their careers, not generalists who have moved into consulting from a different background. 

Our involvement is typically most valuable at decision points: when a programme is being designed, when unexpected data needs to be interpreted, when a regulatory interaction requires careful preparation, or when a difficult strategic choice needs to be made with incomplete information.

Circular diagram showing six interconnected regulatory and product development services: Target Product Profile, Lifecycle Management, Risk Management Planning, Regulatory Strategy for Paediatric Development, Regulatory Strategy, and Due Diligence and Gap Analysis.

How We Work

We do not have a standard consulting methodology that we apply to every client. What we have is experience, and the ability to think clearly about complex problems in a regulated environment. We engage with each client's specific situation and give direct, practical advice. 

Engagements range from single advisory sessions to extended strategic partnerships. The depth of our involvement is calibrated to what the client actually needs, and we are straightforward about when a problem requires a different kind of expertise than we can provide.

Scope Of Service 

  • Development strategy review and planning 
  • Target product profile development 
  • Regulatory pathway assessment and planning 
  • Clinical programme design review 
  • Risk-benefit assessment 
  • Scientific advice meeting strategy 
  • Pre-submission consultation 
  • Data interpretation and gap analysis 
  • Due diligence support for licensing and investment decisions 
  • Expert opinion for regulatory submissions 
  • Programme rescue and recovery planning 
  • Independent scientific advisory board participation
Download our services guide 
Frequently Asked Questions
A target product profile is a document that defines what a medicine needs to look like, in terms of its indication, efficacy, safety and other characteristics, for it to be commercially viable and approvable by regulators. It is essentially a specification for the end product, written before the development programme is complete.

Having a clear target product profile allows a sponsor to design their development programme with a specific goal in mind, and to make decisions along the way that are consistent with achieving that goal.
Yes. We regularly provide scientific and regulatory due diligence support for transactions involving clinical-stage assets. This involves a thorough assessment of the development programme to date, including the clinical data, the regulatory history and the proposed pathway forward, and a frank evaluation of the risks and uncertainties that remain. 

Our reports are intended to give decision-makers an accurate picture of what they are acquiring or investing in.
Programmes run into difficulty for many reasons, and the path forward depends entirely on what has gone wrong and at what stage. We approach these situations directly, without false reassurance, because the first requirement of a programme rescue is an honest diagnosis of the problem.

From there, we work with the sponsor to assess the options that remain and to make the best possible case for the programme going forward.

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