We support clinical-stage biotech and Cell and Gene Therapy companies in their most critical GMP transitions — from early clinical supply to commercial readiness.
From clinical batches to commercial supply — we help you build GMP systems that scale with your business and regulatory requirements.
Support for IMPDs, INDs, BLA/MAA submissions, and health authority interactions. From CMC dossier sections to regulatory strategy — bridging science, manufacturing, and compliance.
Fit-for-purpose Quality Systems tailored to your size and stage — ensuring GMP compliance without unnecessary bureaucracy.
Selection, qualification, and active management of your external manufacturers — ensuring your CDMO delivers GMP-compliant products you can trust.
Prepare your facility and teams for FDA inspections — including PAIs, routine inspections, and remediation support after 483s.
From process development to commercial readiness — supporting transfers to CDMOs or in-house manufacturing facilities.
Identify GMP and manufacturing risks before investments or acquisitions — providing clear, actionable insights to VCs and strategic buyers.