Pharmaceutical & Biotech Quality Assurance Services
Quality Assurance services support the governance, oversight, and compliance of regulated activities across the product lifecycle. We partner with Pharma and Biotech companies, sponsors, manufacturers, and CROs to deliver Quality Assurance support that strengthens regulatory compliance, inspection readiness, and the systems that protect patient safety and product quality across the lifecycle.
Our Quality Assurance services help organizations manage GxP compliance, maintain control of regulated activities, and demonstrate effective oversight to regulators such as the FDA, EU regulatory authorities, MHRA, and other global authorities, while supporting robust, sustainable quality systems.
The role of Quality Assurance in Pharma and Biotech
Quality Assurance plays a crucial role in how Pharmaceutical and Biotech organizations maintain control, manage risk, and demonstrate compliance across the product lifecycle, from early development through to commercial supply and post-market oversight.
Quality Assurance provides independent oversight to ensure quality systems, products, and operations.
This includes:
- Ensuring governance frameworks are fit for purpose
- Products consistently meet approved requirements
- Day-to-day operations align with internal procedures
- Regulatory expectations across GCP, GLP, GVP, GMP and GDP environments, in line with global frameworks such as FDA, EMA, ICH.
In this context, QA is not simply for inspections. It acts as the interface between operational delivery and regulatory accountability, enabling consistent, risk-based decision-making and continuous improvement.
When quality systems are designed and applied effectively, inspection readiness becomes a natural outcome, and patient safety is protected by preventing quality failures before they occur.
Effective Quality Assurance reduces regulatory risk, improves operational efficiency, and supports timely progression from development to market entry by embedding quality into day-to-day operations rather than relying on reactive controls.
Why Quality Assurance is critical in Pharma and Biotech
Quality Assurance is a strategic capability that underpins regulatory confidence, product quality, and long-term operational sustainability.
Effective QA enables organizations to scale, adapt to regulatory change, and maintain control across increasingly complex development and supply environments.
Through proactive quality systems and proportionate oversight, QA enables organizations to maintain compliance while supporting innovation, scalability, and increasingly complex manufacturing and development models.
With clear advantages towards:
Patient safety and compliance control - Effective QA oversight supports patient safety by ensuring quality systems operate as intended, while also reducing the likelihood of inspection findings, delays, and supply disruption.
Regulatory confidence - Supports consistent, risk-based compliance with expectations from regulators such as the FDA, EMA and MHRA, helping organizations approach inspections with confidence.
Operational efficiency and speed to market - Strong QA enables smoother inspections, controlled change, and more efficient progression from development through to commercial supply.
Consistency across complex systems - QA provides structure and oversight across global supply chains, outsourced partners, and digital quality systems, maintaining consistency, data integrity, and control.
Our pharmaceutical Quality Assurance services
Our Quality Assurance services are delivered as a coordinated portfolio, supporting organizations across various stages of maturity and regulatory exposure. Each service is designed to strengthen compliance, inspection readiness, and quality governance without unnecessary complexity.
We support the design, implementation, and remediation of pharmaceutical Quality Management Systems aligned with regulatory expectations. Our QMS services help organizations establish scalable, phase-appropriate systems that support clinical, manufacturing, and commercial operations.
Well-designed QMS frameworks support consistent decision-making, clearer accountability, and smoother progression from development through to commercial operations.
- Development and optimization of SOPs, policies, and quality governance frameworks
- Scalable QMS support across lifecycle stages
- Alignment with FDA, EMA, MHRA, and ICH expectations
Qualified Person (QP) services
Manufacturing Authorisation holders are mandated by law to maintain a continuous presence of at least one Qualified Person (QP).
We provide experienced Qualified Persons to certify batches of medicinal products before they are allowed for sale or use, ensuring compliant batch certification and release across clinical and commercial supply.
- Batch certification and release for IMP and commercial medicinal products
- Ongoing QP oversight and quality decision-making across the product lifecycle
- Support during inspections, audits, and regulatory interactions, ensuring quality decisions are clearly documented and defensible
- Local in-country QPs across Europe, supporting national requirements and supply continuity
We specialise in providing in-country interim QP services for the certification of both commercial products and investigational medicinal products. Our QPs bring extensive experience across diverse biotech and pharmaceutical products, including:
- Tablets and capsules
- Liquids
- Topical
- Sterile
- Biologics
- Advanced Therapy Medicinal Products (ATMPs)
- Blow-Fill-Seal
- PET Radiopharmaceuticals
Responsible Person (RP) services
Our Responsible Person services support GDP-compliant distribution and wholesale supply activities, providing oversight of quality, compliance, and regulatory obligations across the supply chain. Effective RP oversight helps maintain continuity of supply while ensuring GDP requirements are embedded into day-to-day distribution operations, not treated as standalone compliance activities.
- RP oversight for GDP-regulated operations, including wholesalers and distributors
- Support with RP duties, procedures, deviations, and inspection readiness
- Alignment with EU and UK GDP requirements across distribution networks
- Local in-country RPs across Europe, supporting national requirements and continuity of supply
It is the responsibility of the RP to:
- Implement and uphold Wholesale Distribution Authorisation, registering with Health Authorities for pharmaceutical product storage and distribution.
- Have experience liaising with regulatory authorities, such as the FDA, EMA and MHRA.
- Ensure compliance with GDP Requirements, covering documentation control and all stages of storage and distribution.
- Adhere to EU GDP guidelines and EU/UK Legislation, fulfilling all principal duties and responsibilities of the RP.
- Provide competent authority inspection readiness and GDP auditing.
Mock Inspections
We deliver mock inspections led by former health authority inspectors, aligned with real-world expectations from global regulators including the FDA, EMA, MHRA, and PMDA.
Our mock inspections assess inspection readiness across quality systems, processes, documentation, and teams, applying regulatory guidance through the lens of real inspection experience and current authority expectations.
- Independent identification of gaps and remediation priorities, with a focus on system effectiveness and regulatory expectations
- Inspection preparation and post-inspection follow-up support, informed by regulator insight
- Global inspection experience, tailored to authority-specific focus areas and inspection styles
Training
We provide quality and GxP-focused training to support inspection readiness, consistent execution, and the development of a strong quality culture across teams.
- Role-based and risk-based training programs
- On-site, remote, or hybrid delivery models
- Training aligned to real-world operations, regulatory expectations, and quality system maturity
How we deliver our Quality Assurance services
Our Quality Assurance services are delivered through flexible, scalable models that prioritize regulatory alignment and inspection-focused outcomes.
Our approach
- Risk-based and proportionate
- Regulator-aligned
- Phase appropriate
- Sustainable
- Practical, implementable outcomes
- Senior consultant-led delivery
Delivery models
- On-site QA support
- Remote or hybrid delivery
- Full QA program management
- One-off remediation or inspection support
- Multi-year quality partnerships
Trusted by top-tier teams worldwide
Featured case studies
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as requested Review Marketing Authorisation variations Perform training with impacted…
FAQs
At Apotech, we offer full transparency on our Quality Assurance services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, we have an amazing team of consultants who work with us to perform local activities such as batch release or authoring SOPs in local languages.
As we understand each country's specificities, we can supply you with the right qualified person, according to the local regulations required.
Helpful resources
10 CAPA Metrics and KPIs Every Quality Team Should Track
By Imane Nohair, GxP Audit manager at Apotech Corrective and Preventive Actions (CAPAs) are a fundamental element of quality management across the pharmaceutical & biotechnology industries. When designed and executed effectively, CAPAs do more than address isolated non-conformities. CAPA processes strengthen quality systems, reduce regulatory risk, and support sustained compliance across global regulatory frameworks. Across…
GxP Compliance Explained: Beyond Best Practice
Understanding the meaning of GxP is essential for any organization operating in the life sciences sector. In simple terms, GxP refers to “Good Practice” quality and regulatory guidelines, used to ensure products are safe, effective, and reliable throughout their lifecycle. These standards apply across pharmaceuticals, biotechnology, medical devices, and laboratory environments, and are enforced by…
How To Master The CAPA Process Step-by-Step: From Identification to Implementation
The Corrective and Preventive Action (CAPA) process is a core mechanism within Pharmaceutical and Biotech quality systems, designed to identify, address, and prevent issues that may impact compliance, product quality, and most importantly, patient safety. In regulated environments, CAPAs are not isolated actions but structured responses embedded within a wider quality management framework. CAPAs are commonly triggered by internal…
Get in touch
Quality Assurance underpins regulatory confidence, sustainable growth, product quality, and ultimately, patient safety. Speak with our team to discuss how our Quality Assurance services can support your organization.