GMO Application Service

GMO application preparation

• Authoring and review of environmental risk assessments (ERA), GMO technical dossier, and supporting documentation for contained use, deliberate release for clinical trial applications.

Integrated CMC–biosafety–environmental strategy

• Consolidation of CMC, biosafety, and environmental risk considerations into a single, coherent strategy to support GMO requirements for clinical trial applications.

Facility & process description support

• Preparation of detailed descriptions of manufacturing sites, containment measures, and operational controls required for GMO submissions.

Submission management

• Coordination and management of global GMO submission processes, including compilation, formatting, submission to biosafety authorities, and tracking of review timelines and follow‑up requests

Not fully confident in your GMO regulatory pathway?

Clinical trials involving genetically modified organisms — including viral vector-based gene therapies, CAR-T products and other GMO-classified advanced therapies — require GMO regulatory approval alongside the standard clinical trial application. This is a specialist area that sits at the intersection of CMC, biosafety and environmental regulation.

Minerva provides end-to-end GMO application support for ATMP and gene therapy developers in the UK and EU, integrating GMO regulatory requirements into the broader CTA and clinical development strategy from the outset.