Case Study 35: Fast-Track Qualification of an OSD CMO in Vietnam for a Scandinavian Pharma Company
Client: A Scandinavian pharmaceutical company launching a niche OSD product
Challenge
The client selected a Vietnamese CMO offering low-cost manufacturing but lacked EU GMP certification. They needed to qualify the facility while addressing gaps in documentation and process controls.
Solution by Qualifyo:
Performed a two-phase audit: a pre-audit review of documentation remotely and a detailed on-site audit to assess manufacturing practices.
Provided technical consulting to the CMO on process validation, quality control, and equipment qualification. Implemented bilingual documents to make their system robust.
Delivered an actionable audit report and a roadmap for the CMO to achieve EU GMP compliance.
Outcome:
The CMO achieved compliance within six months, meeting the client’s aggressive timeline for market entry.
The client reduced manufacturing costs by 30%, making the product more competitive in the EU market.
Qualifyo’s single-window service saved the client from managing multiple consulting firms, cutting qualification costs by 35%.
