ILAP Submissions

"Niche has provided us with dedicated clinical services since we started our company and continues to deliver the highest level of professional services, providing efficient and comprehensive study oversight."

Gill Dines
Head of Clinical Development

RespiVert

The UK’s Innovative Licensing and Access Pathway

An early adopter of the Innovative Licensing and Access Pathway (ILAP), Niche Science & Technology Ltd was the first CRO to submit a successful ILAP application.

We have the experience and understanding of the ILAP pathway to guide you in your submissions to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Profiling within the scientific literature provides a major contribution to the successful launch of a product. It also provides the reference source for monographs, advertising, sales force documents and other promotional material before and after launch.

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Supporting Case Histories

ReCode Therapeutics Inc.

ReCode is developing therapeutics for genetically defined diseases with no existing treatment options including cystic fibrosis and primary ciliary dyskinesia.

Niche supported ReCode Therapeutics in launching their first UK patient study, delivering end-to-end clinical and...

Erytech Pharma SA

Erytech Pharma is a clinical-stage biopharmaceutical company best known for its proprietary ERYCAPS® red cell encapsulation platform

Niche partnered with Erytech Pharma to rescue and rewrite substandard clinical study reports, delivering a high-quality...

DemeRx

DemeRx is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of addiction.

Niche provided DemeRx with end-to-end support to launch a pioneering ibogaine addiction trial, covering site...

Regulatory Strategy

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Medical Illustration

Telling a story is essential to any presentation and our team integrates technical artistic ability with a comprehensive understanding of medicine and science.

Study Documents and Delivery

Clinical trials require the production and maintenance of a wide range of essential documents to ensure that the trial is conducted in a rigorous and ethical manner.

Grant Applications

We tailor our services to fit your needs based on your scope of funding, organisation and the level of support you require. Our team can support all your writing needs.