GMP & GDP - Quality Assurance Consulting

WE INCREASE GMP & GDP COMPLIANCE

PCS Provides GMP & GDP Quality Assurance (QA) Consultancy Solutions in Pharma

Our Quality Assurance Consulting Services

Many organizations are struggling to increase GxP compliance while reducing overhead costs.

The Quality Management Systems have matured in terms of documentation and there is an ongoing struggle to reduce batch rejections and deviations without increasing the amount of rules, supervision and QA personnel.

PCS is at the forefront of remedying this dilemma by employing Quality Culture initiatives which connect people to quality, centralizing the core process(es) and stimulating a productive and innovative working environment.


Our QA Consultants

Experienced Professionals

PCS can provide seasoned experts to tackle any GMP/GDP-related issue you may be encountering. With twenty-six years of experience in the pharmaceutical industry we have dealt with a myriad of situations, problems and challenges. You can view our recent experience here. Our experts can offer a range of services from reviewing existing documentation to creating entire new Quality Management Systems.

Areas of Expertise

Our consultants are experts in the fields of Good Manufacturing Practices, Good Distribution Practices for producers of Finished Products, Intermediates, Excipients and Active Pharmaceutical Ingredients. In addition PCS can assist the Food and Chemical industries with Quality Assurance related issues.

Common QA Consultancy Assignments

The list below represents the most common functions the consultants of PCS are requested to fulfill.

  • Interim Quality Assurance Manager
  • Interim Qualified Person
  • Interim Responsible Person
  • Interim Plant Manager
  • Interim Corporate Quality Assurance
  • Interim Quality Control Manager
  • Interim Quality Assurance Officer
  • Interim Project Lead

GMP Audit Gxp Audit GDP Audit GMP Supplier Qualification

Our Principles

In a Nutshell

We believe that our principles are at the core of everything we do. As a client of PCS you can be assured that we will conduct every assignment with integrity.

We deliver as promised and remain committed to delivering excellent customer service. You may depend on PCS to deliver quality; we will always provide an expert suited for the assignment.

As PCS promotes an efficient and honest working culture you may rely on us to have your best interests at heart, the essence of the problem will always be discussed.

During the execution of every assignment our experts will connect people and quality, creating an ideal combination for ensuring compliance to the leading regulations.


Our Advantages

Global Experience

Our Quality Assurance Consultants have performed a significant number of assignments globally, in a range of different industries.

Broad Knowledge

We are a dedicated team of Quality Assurance Consultants who know all ins and outs of Quality Systems and its potential issues.

Seasoned Consultants

Our Quality Assurance Consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.

Ready to Improve Your Quality Assurance Activities?

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Overview of Quality Assurance Consulting Solutions

Click here to contact us if the service you require is not listed below.

  • 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

Regulatory Inspection Preparation for:

  • 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