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.
Our Regulatory Affairs team has extensive global working relationships with MHRA, EMA, HTA, and FDA.
Benefit from our expertise in:
Advice on your national or global regulatory strategy
Supporting early interactions with regulatory agencies
CMC gap analysis
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)
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?
Contact us today to find out how we can support you.