Single-Point Batch Release
From released batch to the investigator site — including the paperwork.
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A filled vial is not a clinical batch. Labeling, testing, release documentation, storage and shipping stand between the filling line and a unit that can be administered under your protocol. We close that gap, and we write the CMC sections that go with it — drawing on a team that has taken a nanomedicine through FDA IND approval.
What we offer
1
Primary packaging & labeling (10 mL RTU vials, ISO 8362)
Deliver primary packaging in 10 mL RTU vials with protocol-specific labeling. Container closure integrity testing supported, appropriate to the container system and stage.
2
In-house sterility testing & 100% visual inspection
Perform sterility testing in a dedicated Grade B sterility suite and 100% visual inspection in-house, with extended analysis through qualified partner laboratories.
3
cGMP/EU GMP-compliant batch release
Release cGMP/EU GMP-compliant batches with a complete documentation package — batch record, manufacturing report and CoA.
4
CMC documentation & regulatory support (CTD Module 3)
Provide CMC writing and regulatory support, including drafting Module 3 drug product sections on request, from a team with direct FDA IND approval experience.
5
Controlled cold storage & global distribution
Hold released material under controlled temperature, including frozen conditions, with continuous temperature monitoring. Coordinate global distribution through qualified logistics partners.