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Engineering Services

By choosing Apotech for your pharmaceutical and biotech engineering needs, we ensure your projects not only meet the regulatory standards required but also perform with operational excellence.

Optimising validation and compliance processes

Partner with us for dedicated engineering support

At Apotech, our team is comprised of highly qualified consultants who specialise in providing comprehensive services tailored to the unique needs of the pharmaceutical and biotech industries. 

In addition to the wide range of system quality assurance services we offer already, our team can also provide you with dedicated assistance on any engineering and manufacturing projects you need regulatory support on. 

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Commissioning, Qualification and Validation (CQV) 

Our comprehensive CQV services are designed to ensure that your facilities, utilities and equipment meet all regulatory requirements, are fit for purpose and operate within designated parameters. From the initial design and validation master plan up to performance qualification, we provide end-to-end support to guarantee compliance and operational excellence.

Our portfolio of CQV services include:

  • Validation master plans
  • Author qualification protocols (IQ, OQ and PQ) 
  • User Requirements Specifications (URS)
  • Functional specifications (FS) 
  • Detailed design specifications
  • Design qualification 
  • Cleaning validation (CIP) 
  • Sterilisation validation (SIP) 
  • Validation of utilities (such as HVAC, compressed air and water systems)

Computer System Validation (CSV) 

By utilising our expertise in GAMP and adhering to industry best practices for Computerised System Validation, we offer risk-focused validation services that are tailored to both small and large systems. 

Our extensive experience within this area spans the validation of computer systems across the GxP spectrum, encompassing laboratory information management systems, manufacturing materials management and dispensing systems, clinical trial management, regulatory document management submissions (CTD/eCTD), pharmacovigilance systems and infrastructure services such as IT service desks, data centres and networks.

  • Author validation and qualification plans
  • Author validation and qualification protocols
  • User requirement specifications (URS) & requirement traceability matrices
  • Test plans, specifications and reports
  • System validation and user test management
  • System administration, maintenance and usage SOPs
  • CSV auditing 

Process Validation

Guaranteeing that your processes produce consistent results that meet predetermined quality criteria is the heart of what we do. 

Our process validation services cover initial validation, process verification and ongoing monitoring, helping ensure your operations comply with global regulatory standards and best practices.

Data Integrity 

Data integrity encompasses several key principles, including completeness, accuracy, consistency and authenticity. In pharmaceutical Computerised System Validation (CSV), ensuring data integrity is essential for guaranteeing that electronic records and signatures are dependable and reliable, while also following regulatory standards, such as those detailed in 21 CFR Part 11 and Annex 11 of the EU GMP guidelines. 

This is paramount for upholding the integrity of vital data on manufacturing processes, laboratory testing, clinical trials and pharmacovigilance endeavours.

Our data integrity services include: 

  • Data Integrity Assessments 
  • Policies & Procedures Framework 
  • Training for your organisation (link to training page)

Technology Transfer

Our technology transfer services are tailored to support the seamless transfer of processes and products from development to commercial-scale production, or from CDMO to CDMO as well. 

We focus on risk management, scalability and compliance, ensuring a smooth transition that maintains product quality and integrity. 

We've also had the opportunity to participate in highly challenging global technology transfer initiatives over the past few years, so take a look at our case studies below to see some of our previous work.

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Our range of Pharma and Biotech engineering services

Working around your specific circumstances and regulatory needs, we offer a number of engineering services that have been specifically designed for the pharma and biotech industry. 

Whether you need support in creating a validation master plan, validating an existing computer system or performing a technology transfer, our team have the experience and expertise to help.

Featured case studies

Medical device CSV

Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…

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