GMP & GDP Consultancy
For pharma and supporting industries
PCS has the experience and expertise to analyse your current situation accurately and help you navigate the regulatory hurdles.
- Brexit Support
- GMP for Medicinal Cannabis
- GMP & GDP Licensing
- GMP & GDP Upgrade
For WHO, EMA and U.S. FDA regulated pharmaceutical producers and distributors
- Inspection Preparation
- (Interim) Quality Assurance
- Pharmaceutical Engineering
For GMP & GDP regulated organizations including FDF, Intermediates, API and Excipient Manufacturers
Manufacturing and Distribution License Support, QP Support, QP Training, Interim QP Services
For (potential) manufacturers of medicinal cannabis
For individuals and organizations wanting to obtain a GMP or GDP license
WHO Pre-Qualification, U.S. FDA Inspection Preparation, PIC/S Compliance Solutions, EMA Inspection Preparation
For organizations with a (pharmaceutical) quality system
New GxP facilities, validation, qualification, training and overall GxP adherence
"PCS (est. 1990) is your partner for GMP & GDP consultancy."
PCS is a well-known pharmaceutical (GMP and GDP) consultancy and training provider. We connect people and organizations to the essence of excellent quality, functional processes and effective working cultures.
Proven Track Record
- Serum Institute of India (Pune). Support in the design and construction and implementation of quality systems for three new buildings including two vaccines and one sterile finished dosage form. FDA approved.
- Assistance in start-up and quality systems for Protein Sciences (Meriden U.S.). FDA approved.
- Long-term support for Boehringer Ingelheim IT, (Biberach, Germany). FDA approved.
- Long-Term QA support for Roche (Mannheim, Germany). FDA approved.
- WHO Prequalification audit and support for Yuxi Walvax (China).
- Acambis (Cambridge U.S.) QA support in startup and operation of a vaccine manufacturing plant. FDA approved.
- Genibet (Lisbon, Portugal). Design Qualification of a Biotech Manufacturing facility and QA support to Licensing. EU approved.
Our consultants have performed a significant number of assignments globally, in a range of different industries.
We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.
Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
Overview of Our Services
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- GAP Analysis and Benchmarking
- Risk Assessments of (Proposed) QA Systems
- Development of Pharmaceutical Quality Systems & Quality Culture
- Definition of Suitable Metrics for Quality Monitoring and Improvement
- Practical Implementation Support of Entire Quality Systems or parts thereof
- Coaching and training of personnel at all levels within the organization in the principles and practice of Quality Systems
- Independent inspections to determine ongoing compliance to in-house, corporate or official Quality System requirements
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- World Health Organization (WHO) Qualification
- World Health Organization (WHO) Pre-Qualification
- Russian Good Manufacturing Practices (SID & GP)
- Indian National Regulatory Authority (NRA)
- Other National Regulatory Authorities