GxP Audit Services
As one of the life sciences industry's leading Quality and Audit Consulting firms, Apotech uses a modern and flexible approach to meet all of our client’s global audit requirements.
Embrace a modern approach to auditing
Global complexity, simplified locally
From managing your full auditing program to delivering a single audit on an ad hoc request, we provide tailor-made audit offerings across a wide range of areas within the life sciences industry.
These include Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Computer System Validation (CSV) auditing services – all of which are designed to ensure complete compliance.
Trusted by top-tier teams worldwide
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
Audits conducted in 2023
A network of Auditors / GxP areas
Coverage of countries
Why choose Apotech’s auditing services?
At Apotech, our onsite or remote audits help pharmaceutical, biotechnology and medical device companies maintain the highest standards of quality and safety. Thanks to our in-house auditing experience, we provide tailor-made solutions that you can trust.
We offer a global reach
With more than 800 Lead Auditors across every major global country, we can offer bespoke guidance to support your auditing requirements.
We’re experienced
Our auditors have a minimum of 20 years of experience and have individually led over 100 audits for various companies across the life sciences sector.
We provide competitive pricing
Our pricing model is competitive and keeps the costs required for expenses and travel purposes at a minimum.
We speak your language
Wherever you are in the world, our auditors can perform audits in a wide variety of countries and communicate with you in your local language.
The benefits of an onsite audit
Onsite audits are pivotal for GxP pharmaceutical practices.
Not only do they ensure regulatory compliance but they also play a key role in verifying documentation accuracy, conducting risk assessments and inspecting facilities to maintain optimal conditions.
By evaluating personnel competency and assessing supplier performance in this way, onsite audits contribute to the continuous improvement of processes and systems, helping ensure only the most reliable information is submitted to regulatory authorities.
FAQs on Audits
We provide a modern approach to auditing that offers full transparency. 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, our team can provide comprehensive CAPA (Corrective and Preventive Action) Management support.
Our modern and flexible approach ensures effective handling of CAPA processes, helping not only address and prevent any non-conformities but also contribute towards the continual improvement of both quality and compliance.
Featured case studies
GMP Audits
GMP Audits Introduction UK Based Biotech The company is a worldwide large biotech with a vast portfolio of biotech products (mainly oncology). Apotech auditors: 3 auditors are involved in this partnership. Types of Audits Contracts/agreements between the clients and the provider GMP/GDP Client SOPs Local regulations Audit Locations Europe The audited sites are: Client manufacturing…
GxP Audits – Worldwide
GxP Audits – Worldwide Introduction Global Biopharmaceutical Our client is a global biotechnology company dedicated to novel treatments for patients through inhibition of protein kinases to fight cancer. They are Headquartered in the US, with a large footprint in the EU. Types of Audits GCP – For Cause / Investigator / Phase 1 unit GCLP – Central…
GCP Mock inspections – Europe
GCP Mock inspections Europe Introduction Danish R&D Pharmaceutical Company Our client is a pharmaceutical company committed to ensuring compliance with global regulatory standards, particularly FDA requirements for clinical trials Apotech auditors Our Auditors have 20+ years’ experience, all based locally with extensive experience in FDA inspections and GCP compliance. Collectively conducted over 50 regulatory inspections…
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