Search Results

Enter a query to start searching.

WHO GMP Consultancy, Vaccine & Biopharmaceutical Consultancy

PCS provides extensive support to pharmaceutical companies aiming to meet WHO GMP standards, often for manufacturers of vaccines and biopharmaceuticals.

Used by

Abbott
Roche
Pfizer

Plan a meeting in our agenda

Or

By submitting this form, you agree to our Terms, Privacy Policy and Cookies Policy.

Why you should choose PCS for WHO GMP, vaccine or biopharmaceutical consultancy projects

  • Extensive experience in WHO GMP and WHO prequalification
  • Completed more than 20 international projects in WHO GMP
  • Expertise in large-scale vaccine and biopharmaceutical manufacturing
  • Helped with the construction of manufacturing facilities under WHO GMP
  • Our consultants are process-engineers and manufacturing experts

Get the right experience with PCS

Our Support

PCS provides extensive support to pharmaceutical companies aiming to meet WHO standards for prequalification. We assist with:

  • WHO Prequalification Dossier Preparation

  • Upgrading WHO GMP

    Assistance after disapproval or in preparation to sell to WHO.

  • Establishing WHO GMP Compliant Facilities

    From strategy to full-scale factory establishment with the client's engineering firm.

  • Reconstructing Vaccine and Biological Facilities Globally

  • Reobtaining WHO GMP Certification

    Ensuring successful WHO inspections worldwide.

  • Interim QA Management

    Quality culture enhancement to regain WHO compliance.

Key Projects

  • BB-NCIPD

    Addressed quality control issues for a tetanus-diphtheria vaccine.

  • Bharat Biotech International Limited

    Supported WHO prequalification audit and GMP QA improvements.

  • Panacea Biotec Supported with WHO prequalification and interim Quality Assurance management on site in India.

  • Protein Sciences Supported with the re-construction of a novel protein platform manufacturing facility and interim Quality Assurance management in the United States as head corporate Quality Assurance.

  • Serum Institute Long term support with WHO prequalification for a new polio platform and re-construction of facilities. As well as supporting the construction of a new facility under WHO GMP.

  • Indian Immunologicals

    Assisted in design, construction, and operation of new vaccine facilities.

  • Institute of Immunology

    Conducted full GMP audits and implemented WHO GMP standards.

  • Sovereign Pharma

    Implemented WHO GMP for vaccine introduction.

  • Sinovac

    Conducted a WHO prequalification audit for vaccine production.

  • UNIDO

    Audited Zimbabwean pharmaceutical companies against WHO GMP standards.

  • Yuxi Walvax Biotechnology

    Performed a WHO prequalification audit for bio-pharmaceutical products.

Expertise in Vaccine Consultancy

PCS excels in managing complex biological and vaccine projects under WHO GMP, EU GMP, or U.S. FDA supervision, providing tailored consultancy to meet international standards.

Jaap Koster, CEO of PCS, avatar

PCS ensures your pharmaceutical products meet WHO standards, from prequalification to successful inspections.

Eng. J.J.M. Koster
CEO of PCS

Hiring PCS for WHO GMP quality culture improvement, new construction, re-construction, or re-inspection projects is crucial because of our extensive expertise and proven track record in the pharmaceutical industry. Our experienced team, which includes former regulatory inspectors, provides tailored solutions to ensure compliance with WHO standards. PCS helps identify and address gaps in GMP practices, guides the design and construction of compliant facilities, and ensures successful inspections. This comprehensive support minimizes risks, accelerates project timelines, and enhances overall quality and compliance.

Ready to get started?
Get in touch with us.

Plan a call in our agenda Send a message

Frequently asked questions

How does PCS assist in preparing for WHO prequalification?

PCS provides comprehensive support in preparing the WHO prequalification dossier, ensuring all necessary documentation and data meet WHO standards. Our team guides companies through the entire process, from initial assessment to final submission, helping to navigate regulatory requirements and streamline the approval process.

What steps does PCS take to upgrade WHO GMP compliance after a disapproval?

After a disapproval, PCS conducts a thorough gap analysis to identify deficiencies in current GMP practices. We then develop a tailored action plan to address these gaps, provide on-site training and support, and assist in implementing necessary changes to meet WHO GMP standards. Our goal is to ensure companies achieve compliance and are ready for reinspection.

How does PCS support the establishment of new WHO GMP compliant facilities?

PCS collaborates with the client's engineering firm to develop a strategic plan for establishing WHO GMP compliant facilities. Our services include design review, construction oversight, and validation support. We ensure that all aspects of the facility, from infrastructure to operational processes, adhere to WHO GMP standards, facilitating smooth and compliant operations.

Get the vaccine, WHO GMP or biopharmaceutical consultancy support you need!

PCS provides extensive support to pharmaceutical companies aiming to meet WHO standards for prequalification. We assist with a number of essential activities such as (re)construction, prequalification and/or WHO GMP quality culture turnarounds.

  • Extensive experience in WHO GMP and WHO prequalification
  • Completed more than 20 international projects in WHO GMP
  • Expertise in large-scale vaccine and biopharmaceutical manufacturing
  • Helped with the construction of manufacturing facilities under WHO GMP
  • Our consultants are process-engineers and manufacturing experts
Go to the contact page