White background with no visible content or imagery.

Company: 

Thromboserin

Thromboserin

Thromboserin Ltd. is an ‘innovator’ research company and their mission is to focus primarily on preventing arterial thrombosis. TH001 was granted a US Patent in December 2015, giving them IP until 2030.

  • Thromboserin used Niche's expertise in writing of IBs and previous experience in the therapy area to quickly and efficiently develop the high-quality regulatory documents
  • The Niche team was actively involved in guiding regulatory strategy and meeting delivery timelines

 
What our client said

"We have always been impressed by the standard of the work delivered by the Niche team. In addition, the contracting process is simple and efficient, communication is open, frequent and proactive, with any issues getting resolved quickly and efficiently."

photophotophotophotophoto

Professor Mark Noble

Thromboserin




Request copy of the testimonial
Project background
Thromboserin is a biotechnology company dedicated to advancing the treatment of thrombotic diseases, particularly in the areas of blood clotting and related disorders. The company specialises in developing innovative therapies that aim to improve patient outcomes by addressing the underlying causes of thrombosis. With a strong focus on research and scientific discovery, Thromboserin is committed to pioneering new solutions that provide safer, more effective alternatives to current treatment options. Through its cutting-edge research, the company strives to make a meaningful impact on the global fight against thrombosis and related diseases.
Delivery

Thromboserin first approached Niche to create the Investigator's Brochure (IB) for their product, TH001. This was particularly challenging as the information provided by the original Sponsor was poor quality and in hard copy only. Niche's renowned expertise in the writing of IBs ensured the quick and effective delivery of this document which was used to inform Thromboserin’s Protocol and subsequently used to build their Clinical Trial Application. Niche also aided Thromboserin’s search for development partners to support the company in their clinical development.

Related Case studies

Hand holding a glowing blue digital brain illustration with connected network nodes against a dark blue background.

DemeRx

Regulatory Affairs

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.

read more
Red blood cells floating against a soft blue and white blurred background

Erytech Pharma SA

Regulatory Affairs

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.

read more
Hand holding tweezers extracting a segment from a DNA double helix structure against a blurred laboratory background.

Orchard Therapeutics plc

Regulatory Affairs

Orchard focuses on key competencies internally, while engaging with bespoke service providers to deliver important aspects of their business.

Niche played a foundational role in securing EMA approval for Strimvelis, the world's first ex vivo autologous gene.

read more
Scientific illustration showing blue nerve cells and magnified views of cellular structures including antibodies, bacteria, and cell division processes.

EVERSANA

Regulatory Affairs

EVERSANA is a leading independent provider of global services to the life sciences industry.

When an Alzheimer's programme hit a wall after two negative Phase III trials, EVERSANA called on Niche to make sense of.

read more
Two circular images showing office workers: left shows people at desks with laptops and documents, right shows two men in discussion, overlaid on a network diagram background.

Funxional Therapeutics Ltd

Regulatory Affairs

Providing a broad range of services, as a trusted CRO to help Funxional realise its clinical vision

The clinical evidence Niche helped generate for Funxional's novel anti-inflammatory compound FX125L proved compelling.

read more
Hookipa Biotech logo featuring red text and blue curved design elements forming a circular pattern

HOOKIPA Pharma

Regulatory Affairs

A small but ambitious company with a pioneering vision for their arenavirus platform

Niche prepared the full regulatory package for HOOKIPA's groundbreaking arenavirus immunotherapy platform, enabling the.

read more
Mock passport for drug Roginolisib by iOnctura, showing regulatory approval from MHRA with green APPROVED stamp overlay.

iOnctura

Regulatory Affairs

Evolving study designs and managing complex data outputs to present a comprehensive regulatory package

What began as a CSR writing request grew into a broad regulatory partnership, with Niche guiding iOnctura's roginolisib.

read more
Quality control infographic showing a central magnifying glass with tick mark connected to icons for search, settings, charts, and analytics on coloured circular backgrounds.

Nanomerics

Regulatory Affairs

Niche was invited to provide support for the development of the regulatory documentation for OC134, a reformulation of tacrolimus

Regulatory documentation, ILAP designation and a robust clinical protocol for the Sunlight Trial — Niche helped.

read more
Abstract blue network background with connected dots and lines forming a geometric pattern on dark blue gradient.

VectivBio

Regulatory Affairs

Services were tailored to meet the differing requirements of the regulatory pathway, including providing various study documents and updates.

From Phase I protocols to a full Marketing Authorisation Application, Niche was VectivBio's embedded regulatory writing.

read more

Get our latest news and publications

Sign up to our news letter

© 2025 Niche.org.uk     All rights reserved

HomePrivacy policy Corporate Social Responsibility