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