QMS & WHO PQ support

International regulatory protocols can be a minefield even for experienced professionals. Institutionalisation of QMS is the mainstay for consistent quality delivery. We combine QA with our deep and broad knowledge of the industry, operational expertise and approval protocols accumulated over decades to enable you to put a robust Quality Management System in place.

We help you assess the programmatic suitability of a vaccine for prequalification, adequacy, completeness and accuracy of the data in the product summary file and support in gap analysis of manufacturing facilities and adequacy of the clinical development program for prequalification. We conduct an overall assessment of your preparedness for undergoing WHO PQ with emphasis on the QMS.

We support you through the process and requirements for vaccines considered for WHO PQ, as well as the handling of procedures, methods and documentation involved in the testing of the vaccine samples at WHO appointed laboratories.

While our success stories include clients who have secured WHO pre-quealification for specific vaccine candidates, our domain expertise spans across biologics to support specific audits and projects registrations in key markets.

Our deliverables include

  • Gap analysis of plant and product undergoing WHO PQ per China Pharmacopoeia and WHO TRS
  • Mock audit of all QMS systems
  • Compliance to internal audit and mock audit observations
  • Pre-evaluation meeting with WHO for PQ
  • Internal notes during WHO audit for preparing an action plan and training notes
  • Post audit follow-up/re-audit CAPA submission and compliance

Our clients include pharma and biotech companies.

Strategic Partners

We help local companies and organisations in the developing world secure long-term supply contracts of quality, affordable vaccines and biosimilars through project localisation initiatives and partnerships with established manufacturers of biotech/biological products.

Strategic Partners

We help local companies and organisations in the developing world secure long-term supply contracts of quality, affordable vaccines and biosimilars through project localisation initiatives and partnerships with established manufacturers of biotech/biological products.

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Read the stories behind the science

We helped set up the first indigenous vaccine manufacturing facility in Central America
We enabled the first successful development of a contemporary recombinant vaccine in Turkey

So I can’t show you how, exactly healthcare is a basic human right. But what I can argue is that no one should have to die of a disease that is treatable.

Paul Farmer

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Techinvention featured in Silicon Healthcare’s top 10 promising biotech companies 2019.

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