Every transfer follows a signed protocol with agreed acceptance criteria before the first campaign. Discrepancies are resolved on paper before they become deviations on the plant floor.
Timelines vary by molecule and scope; the shape below applies to every engagement.
Compare sending and receiving site SOPs, equipment, analytical methods.
Signed protocol with acceptance criteria for every critical parameter.
Non-GMP pilot campaign to confirm process transferability.
Three consecutive PPQ batches under GMP with full documentation.
Client-signed transfer closure with data package and CAPA log.
No ambiguity — every parameter has a target and range
Sending + receiving site + client on a single call
Both sites run the method to statistical acceptance
Live matrix updated at every campaign
Recent engagement
Received a validated 3-step synthesis from a European sending site, completed engineering run in 8 weeks, cleared 3 consecutive PPQ campaigns without deviations.
A ten-page PDF written by our subject-matter lead for this capability. Delivered by email within one business day, always signed by a director.
Full-service contract development and manufacturing under one QA framework.
cGMP API and intermediates production at pilot and commercial scale.
Method development to ICH Q2(R2) validation, plus QC release testing and stability studies.
8-14 week engagements that produce 2-3 viable synthetic routes with scorecards.
Small-molecule discovery, process R&D, and green-chemistry alternatives on every route.
Book a call with the Technology transfer lead — no gatekeeping, no BD filter.
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