Regulatory affairs

Advanced therapy medicinal products (ATMPs) face unique regulatory challenges. We support ATMP developers to address specific risks in their product development and satisfy the relevant national and international legislation and guidance.

Our Regulatory Affairs team will help you navigate the UK, EU and international regulatory landscape. We can support you at every stage of the product development: from early development through to clinical trial and marketing authorisation application. Our experienced team can advise on the latest applicable regulations, write or review your applications and help you get the most out of key interactions and meetings with national and international agencies.

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?