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WHO GMP and prequalification consultancy

PCS helps vaccine manufacturers worldwide with achieving WHO prequalification or repairing their WHO GMP compliance status after WHO disapproval.

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Over 20 WHO GMP clients preceded you!

Why should you choose PCS for WHO GMP consultancy

Extensive vaccine and BSL expertise and experience,
Worked with global vaccine manufacturers in achieving WHO prequalification,
Our services are worldwide,
We usually respond within the hour to urgent requests,
Helping companies repair their WHO GMP status quickly and accurate,
Urgent support can be delivered quickly.

Our Commitment

Medicine supplied to the WHO are often provided to patients in challenging environments. Although patient safety is at the core of our business, we emphasize this even more when we’re working on World Health Organization PQ/GMP projects. By emphasizing patient safety we can ensure that organizations such as UNICEF, the ICRC, MSF and UNFPA receive safe medicine of constant pharmaceutical quality. These metrics are essential to the WHO/UNFPA procurement procedure.

Julian Koster, Business Development

Curious to see how we can help you with WHO GMP? Plan a free consult today!

Plan a free consult!

Our Clients

Sinovac, China

PCS provided a WHO GMP mock-audit at Sinovac, China in the run-up to it’s WHO prequalification for a number of Sinovac products. The mock-audit was concluded with good result. Sinovac is one of the world’s leading supplier of COVID-19 vaccines.

Yuxi Walvax, China

In the run-up to WHO prequalification of two manufacturing sites in China, Walvax Biotechnology has asked PCS to perform a WHO PQ mock-audit and consultancy services to Shanghai Zerun Biotechnology. The mock-audit was concluded with good result. Yunnan Walvax Biotechnology is the first company in China to produce a mRNA vaccine against COVID-19.

Panacea Biotec, India

To prepare Panacea Biotec for an upcoming WHO GMP audit PCS deployed a team of expert consultants. The project was completed succesfully with WHO qualification being obtained. The services were performed at a number of sites in Baddi, Lalru, New Delhi and Chandigarh.

United Nations Industrial Development Organization, Austria

A number of leading pharmaceutical organizations in Zimbabwe had to be inspected against the WHO GMP. PCS performed eight WHO GMP audits of these Zimbabwean companies over the course of six months. The audits were executed under the mandate of the United Nations Industrial Development Organisation (UNIDO).

Why choose PCS' consultancy services?

Extensive experience in regulatory inspections and audits,
Our consultants are ex-regulatory inspectors and industry experts, having conducted more than 300 audits each,
Thanks to our international clients we can prepare clients for every regulatory inspection; EU GMP, U.S. FDA, WHO GMP or a combination of these regulatory frameworks,
We know what your clients or the government expects and inspects!
Julian Koster, Business Development

Let me help you explore all the benefits of our services!

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How can we help you with WHO-Prequalification?

Depending on your requirements , PCS can supply you with A-to-Z services for WHO-Prequalification or WHO GMP-Compliance.

Market research
Supply you with details of UNICEF/World Bank tender details
Evaluation of worldwide/regional potential for your product(s)
Assistance with EOI submission to the WHO
WHO GMP mock audit
Mock audit using WHO GMP experts
Comprehensive report on the 17-key elements of the WHO GMP
Recommendations on CAPA's and required investments for WHO GMP compliance/WHO prequalification
WHO GMP implementation
Implementing the CAPA's following the gap assessment
WHO inspection readiness training

Have a question about WHO-Prequalification?

We’re here to help! We usually respond within 1 hour or business day.

Our services are worldwide
We respond to a request within the hour
We take care of the entire process

Contact us

We have the expertise and experience to perform your WHO-prequalification!

Julian Koster
Julian Koster

Business Development

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Available M-F: 09:00 AM to 5:00 PM

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