Quality Assurance Consulting

FOR THE PHARMACEUTICAL INDUSTRY

PCS is one of the most experienced consultancy organizations in Quality Assurance in the pharmaceutical industry.

WE OFFER:

- SOP Writing and Review Services

- Interim Quality Assurance Officers/Specialists

- Interim Quality Assurance Managers

- Interim Qualified Persons

- Process Optimization Specialists

- QMS Re-design or Simplification

Our Unique Approach

Quality Assurance QMS Quality Culture GMP

We connect people to quality

Just compliance is a thing of the past. By connecting people to operational quality you will improve not only compliance but also decrease batch problems.

GMP QMS Consultancy

We understand the word assurance

Accountability is key to assure quality. We support process ownership to inspire a more innovative and responsible working culture throughout all layers of the organization.

GMP QMS Consultancy

We prioritize your core process

Focusing solely on documents alientates you from your core process. PCS helps you retake control of your value adding activities.

(GMP) Quality Assurance Consultancy for the Pharmaceutical Industry.

Our Quality Assurance Consulting Services

Many organizations are struggling to be GxP compliant with costs being a major factor.

The Pharmaceutical Quality Management Systems (PQMS) have matured in terms of documentation and there is an ongoing struggle to reduce batch rejections and deviations without increasing the amount of rules/procedures, 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 Services

QA Services Supported by Our Seasoned Team.

PCS can support your organization with a myriad of services; from writing Standard Operation Procedures (SOPs), helping with Management Review Preparation, reviewing Batch Documentation, providing Quality Assurance Officers and Qualified Persons to restructuring and improving your entire Quality Management System. All our consultants are supported by a team of international experienced, and seasoned, experts. Knowledge is shared internally and resources are pooled to ensure you receive the most cost-effective solution. Is the service you require not listed on this page? Simply use the contact form at the top of this page to get in touch!

Our QA Consultants

Experienced Professionals

PCS can provide seasoned experts to tackle any GMP/GDP-related issue you may be encountering. With more than 30 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?

Fill out the contact form

Fill out the form to submit your request.

GMP auditing services gmp audits

We'll assess your request and find the most economical and efficient solution.

GMP auditing services gmp audits

You'll receive a free quote.

How can we improve your QA department?

Overview of Quality Assurance Consulting Solutions

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

  • SOP Writing and Review Services
  • Interim Quality Assurance Officers
  • Interim Quality Assurance Managers
  • Interim Qualified Persons
  • Process Optimization Specialists
  • QMS Re-design or Simplification
  • 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