Regulatory affairs

Developing an ATMP from the pre-clinical stage through to first in human (FIH) clinical trials is a complex process and requires the development of a robust non-clinical strategy. We strive to help academics, start-ups, and therapy developers with bespoke strategies to ensure effective translation of novel therapies through the non-clinical phases towards clinical trials.

With experience in all aspects of non-clinical studies, from designing proof-of-concept (POC) and efficacy studies, through to FIH supporting pivotal safety good laboratory practice (GLP) programmes, our team employ expert knowledge of the contract research organisation (CRO) landscape specialising in ATMPs and a comprehensive understanding of the ATMP development process to rapidly progress your therapy to the clinic and beyond.

Regulatory affairs

Our Regulatory Affairs team has extensive global working relationships with MHRA, EMA, HTA, and FDA.

Benefit from our expertise in:

Development Support

Advice on your national or global regulatory strategy

Supporting early interactions with regulatory agencies

CMC gap analysis

Regulatory Procedure

Assisting with product ATMP classification

Priority medicines (PRIME)

Regenerative medicine advanced therapy designation (RMAT)

Raw material evaluation

Designation application (e.g., orphan drug designation, rare paediatric designation)

Paediatric plan application

Starting material procurement support

Marketing authorisation/licence application including individual documents (e.g., environmental risk assessment)

Clinical Trials

Access to our clinical network of ATMP experts

Investigational medicinal product dossier (IMPD)/Module 3 authoring, including conversions clinical trial application (CTA/IND), maintenance and interaction with regulatory agencies

CTA authoring (IMPD, IB, Protocol etc)

Genetically modified organism (GMO) application, maintenance and interactions with environmental agencies

National GMO manual authoring

Innovative Licensing and Access Pathway (ILAP)

Integrated input from our Non-Clinical, Regulatory Affairs and HEMA teams to support you with the ILAP process and maximise derived benefits

Working on a cell or gene therapy innovation challenge?