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Our Services

Audit Services

PQP Group experts perform audits and mock inspections across the product lifecycle.

Our team also audits suppliers and service providers to the pharmaceutical industry.

Our team provides the following audits:
Quality Systems Audits (PQS)

The quality system (PQS) ensures that your company operates in a compliant manner. We perform on-site audits across the globe, as well as remote audits. We identify gaps in your PQS and can provide pragmatic solutions for closing them.

Supplier and Contractor Audits

Our quality risk management approach helps you define which third-party companies or contract manufacturing organisations (CMOs) to audit on-site or assess remotely. In addition, we provide global auditing services for material suppliers, including CMOs manufacturing all pharmaceutical dosage forms, excipients, and active pharmaceutical ingredients (APIs).


Good Laboratory Practise, Good Manufacturing Practise, and Good Distribution Practise regulations apply across the supply chain. Our experts perform audits in each of these disciplines to global regulatory standards, including EMA, U.S. FDA, WHO and PIC/S.

Due Diligence for Acquisitions

Use PQP's independent, experienced team of auditors to determine whether your company's future acquisitions are sound or require remediation. Our team's findings help company stakeholders perform due diligence and make critical decisions about the acquisition process.

How Can PQP Help?

Audits by third-party experienced auditors can help pharmaceutical firms to identify possible gaps in GxP compliance. This audit could be of the company’s own facility, perhaps as part of an internal audit programme, or of a supplier to the company.

GxP Inspection Readiness Support

Identify key risks and follow expert mitigation strategies prior to your GxP inspection. We’ll help you prioritise and address concerns, creating perpetual inspection readiness.

When your company embeds quality and GxP compliance into every process, you prepare your team to respond to auditor questions and lay the groundwork for better inspection results.

Designate subject matter experts to own each process, coach them on the inspection process and develop your inspectional readiness programme.

Our independent, proportionate and objective review of your entire quality system ensures that you'll be perpetually ready for GxP inspection, giving you peace of mind.

Gap Analysis

A measured, comprehensive and collaborative gap analysis reveals the effectiveness of your quality system and its compliance with cGMDP requirements. Review and analyse your policies and procedures, facilities and utilities, equipment, materials control, production and laboratories. Evaluate your company's staff behaviour, quality culture and subject matter expertise.

Corrective and Preventive Action

PQP ensures your remediation activities are pragmatic, solution focused, well designed and effective. With controls and monitoring in place, you'll make key investments to achieve the best results.

Investment in Subject Matter Experts

Professional development for your staff is a key part of any improvement project. Our coaching and mentoring methods enhance the expertise and insights of your team and deliver measurable results. We provide science, compliance and leadership-based coaching and mentoring to help your staff prepare, execute and respond to GxP inspections.

Mock GxP Inspections

Our industry experts and former regulatory inspectors provide an unrivalled “dress rehearsal” for your GxP inspection. Receive a pinpoint assessment of your inspection readiness, as well as expert guidance for managing the inspection itself. We can also support you before, during and after the inspection.

Real-Time Inspection Support

We provide strategic interpretation of the inspector’s needs in real time, guide your team to the best outcomes and support immediate corrections, corrective actions and preventive actions.

Post-Inspection Evaluation

Evaluate each concern identified by your regulatory inspector. We'll help you establish a product quality impact assessment, analyse root causes and develop proportionate and sustainable corrective actions or preventive actions. Develop your team, facilitate ownership and always be inspection ready!

Post-Inspection Response and Support

Obtain timely pragmatic solutions for your GxP findings and develop effective next steps to meet regulatory requirements and expectations. PQP provides quick and proportionate response services for GxP deficiencies by identifying root causes and determining effective corrective and preventive actions (CAPAs) to help you avoid costly recurring deficiencies.

We support organisations through risk assessments, product quality evaluations and detailed root cause analysis. In addition to helping our clients revise existing policies, we support the design of new policies, procedures and records. We also ensure sustainable improvements by coaching individual behaviour and supporting changes in team culture.

Fix regulatory issues for the long-term and avoid similar issues in the future through our coaching and mentoring services and simplification projects. Our coaching and mentoring services support effective corrections, corrective actions and preventive actions with sound effectiveness checks.

We also respond to all types of regulatory communications, assist in regulatory meetings and act as expert witnesses or subject matter experts.

We offer the following services:

  • FDA responses

  • EMA responses

  • Regulatory agency meeting preparation

  • Action plan development

Project Management Services

At PQP Group, we understand the complexities and regulations involved in the pharmaceutical industry, especially regarding GxP (Good Practices) standards. Our expert project management services ensure seamless execution of your pharmaceutical projects while adhering to stringent regulatory requirements.

Key Features:

  1. Regulatory Compliance Our project managers are well-versed in GxP regulations, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP). We ensure that your projects comply with all relevant guidelines and standards.

  2. Strategic Planning We develop comprehensive project plans tailored to your specific needs, considering factors such as timelines, budget constraints, and regulatory milestones. Our strategic approach ensures efficient resource allocation and risk mitigation throughout the project lifecycle.

  3. Cross-functional Coordination Effective communication and collaboration are essential for project success. Our project managers facilitate seamless coordination between different teams and stakeholders, including scientists, engineers, regulatory experts, and quality assurance professionals.

  4. Quality Assurance Quality is paramount in the pharmaceutical industry. We implement robust quality assurance processes to monitor and evaluate project performance, identify potential issues early, and implement corrective actions as needed to maintain compliance and product integrity.

  5. Risk Management Mitigating risks is crucial in pharmaceutical projects. Our project managers proactively identify potential risks and develop contingency plans to minimize their impact on project timelines and deliverables.

  6. Documentation and Reporting Detailed documentation and reporting are essential for regulatory compliance and project transparency. We maintain thorough records of project activities, milestones, and deviations, providing you with regular progress updates and comprehensive reports.

Partner with PQP Group for reliable project management services tailored to the unique requirements of the pharmaceutical industry. Contact us today to discuss your project needs and learn how we can help you achieve your goals efficiently and compliantly.

Quality System Support

A strong quality system provides a critical foundation for all pharmaceutical and biotech companies.

Quality Systems

Implementation of quality systems (PQSs) can be difficult. We believe your QS content should be simple and easy to follow, from your quality policy and quality manual to your procedures and work instructions. PQP's team of experts has detailed knowledge of every PQS area. We assign the right expert to review and update your policies and procedures, ensuring they meet global regulatory expectations and requirements.

Process Optimisation

We review and improve processes, offer staff training and qualify people to conduct investigations. We can also support your quality risk management and investigation processes, including root cause analysis. Let us help you develop appropriate corrective actions and preventive actions with sound effectiveness checks.


PQP simplifies standard operating procedures (SOPs) and batch manufacturing records (BMRs) to ensure they are accurate and easy to follow. We work collaboratively to identify the key steps in a procedure or manufacturing process, then design documents using flow charts and decision trees. Our simplification process results in more manageable documents and fewer staff errors.

Cost of Poor Quality Analyses

Highlight manufacturing or testing processes that need improvement with a cost of poor quality analysis. Use cost of poor quality data to encourage senior managers to invest in necessary improvements by shifting the costs associated with rejects, rework, deviations and investigations to positive investments in your company.

Remediation Projects

Develop an action plan for responding to statements of non-compliance, including warning letters and FDA Form 483s. Incorporating our practical remediation solutions into your overall quality system for long-term, sustainable compliance.

In an uncertain world, PQP's remediation expertise helps companies around the globe achieve compliance with optimised, pragmatic and risk-based solutions.

Our team of pharmaceutical consultants includes industry experts to help companies develop strategic plans to address enforcement actions from the FDA, MHRA, EMA and other global authorities.

Respond to adverse regulatory inspection findings, build a compliant quality system or implement a remediation plan to prevent problems in the future. We work with you to build a quality system that is sustainable for your business.

Receive a risk-based gap assessment, corrective action plans and ongoing implementation support. We also provide ongoing coaching and mentoring for team members at all levels to ensure your culture changes in a sustainable way.

We use a systems-based approach to compliance and cover all major pharmaceutical subsystems, including:

  • Quality systems

  • Laboratories

  • Material controls

  • Facilities and utilities

  • Production

  • Packaging and labelling

Operational Support

Receive an expert assessment of your resourcing and training requirements, facilities, equipment or products.

Facilities and Equipment

Whether you need an expert assessment of a specific technical issue or a complete review of your new or existing facility, PQP provides a full range of services to ensure your facilities and equipment are qualified and validated, meeting applicable requirements and standards.

Our services include:


  • Facility review or design

  • Process scale-up

  • Computer systems validation

  • Facility, equipment and utility validation

  • Process validation

  • Tech or design transfer

  • Troubleshooting


Our experts have comprehensive knowledge of regulatory requirements and agency interactions as well as the technical expertise to solve complex issues. We utilise a systems-based approach to compliance within the major pharmaceutical subsystems, including facilities and utilities, laboratories, material controls, production systems and packaging and labelling.

PQP covers the manufacture of all major dosage forms, including sterile and biotech products. We have experience in the following areas:


  • Pharmaceutical packaging

  • Sterilisation applications and processes

  • Pharmaceutical microbiology

  • Supply chain assurance

  • Good Distribution Practice (GDP)

  • Process and analytical method validation

  • Regulatory compliance for computers and automated control systems

  • Pharmaceutical water systems

  • Providing guidance on product manufacturing and product specifications, including the review and preparation of chemistry, manufacturing and control filings

  • Troubleshooting and investigation into product issues

  • Suggesting and implementing appropriate and robust corrective actions and preventive actions

  • Improving and simplifying product- or process-specific documentation


Our services include:


  • Providing guidance on product manufacturing and product specifications, including the review and preparation of chemistry, manufacturing and control filings

  • Troubleshooting and investigation into product issues

  • Suggesting and implementing appropriate and robust corrective actions and preventive actions

  • Improving and simplifying product- or process-specific documentation


Diligence Technical Assessments

We offer a range of diligence and 'mock' assessments on on companies and assets within the Pharmaceutical, Biotech and Cell and Gene Therapy Space. This helps investors assess risks and value companies and assets more accurately, or prepare our clients for such assessments. Such diligence assessments can be tailed and scoped to the needs of the client, but incorporate the following aspects (as required): 

  • Licensing and compliance 

  • Quality Management Systems 

  • Personnel, resourcing and organisation structure 

  • Facilities, engineering and controls 

  • Site capabilities and capacity analysis

  • Site asset control and acquisition

  • Site financial running costs 

  • Remediation analysis and costing 

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