What we deliver
Orphan & PRIME designations
Preparation of orphan drug designation and PRIME eligibility applications to accelerate development.
Potency assay strategy
Development and validation support, including demonstration of correlation with the product's mode of action, establishment of assay suitability, and generation of validation packages.
ATMP classification & strategy
Classification requests to the EMA Committee for Advanced Therapies (CAT) and regulatory roadmaps tailored to your cell or gene therapy.
MAA preparation for ATMPs
End-to-end support for centralised marketing authorisation applications, including CAT rapporteur interactions and PRIME engagement.
Clinical trial applications
Preparation of CTA submissions for ATMP trials, including GMO considerations and national competent authority requirements.
Quality & CMC for ATMPs
Guidance on starting materials, donor eligibility, product characterisation, control & stability strategies and comparability for living products.
Cell and gene therapy start-ups approaching first-in-human trials
Academic spin-outs navigating ATMP classification
Developers preparing for EMA CAT or national authority interactions
Teams planning EU market entry for an approved ATMP
Who we work with
Relevant expertise
Discuss your ATMP programme
Regulation (EC) No 1394/2007 and the ATMP framework
EMA CAT interactions and ATMP classification
Gene therapy vectors (AAV, lentiviral) and genome editing
Autologous and allogeneic cell therapies, including CAR-T
GMP for ATMPs and traceability requirements
PRIME, orphan designation and paediatric investigation plans
Tell us where your programme stands and where it needs to go. We'll outline how Minerva can help and propose next steps..