Good Vigilance Practice (GVP) Audits

At ADAMAS, we are continuing to build on our reputation as the leading international service provider for the provision of GVP full system and process audits worldwide.

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Pre and Post Marketing Full System GVP Audits

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Tailored GVP Process Audits

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Mock GVP Inspections & Inspection Readiness

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Management and delivery of global GVP audit programmes

Consultancy for global risk-based GVP audit strategy and planning

Pre-Inspection gap analysis and Inspection readiness

Post-Inspection CAPA formulation and response

At ADAMAS we place significant emphasis on adding value to the GVP services we provide.

Our in-house GVP consultancy team has been developed based on the principle of significant industry, regulatory and international experience and includes both former inspectors and industry experts.

This ensures that we have an understanding of the regulatory requirements, and that we can deliver first-hand experience on Competent Authority expectations and how GVP requirements are pragmatically applied in industry today.

In 2015/2016 alone, ADAMAS conducted GVP audits in over fifty countries and has successfully managed global headquarter, affiliate, business partner and service provider audit programmes for several pharmaceutical organisations, ranging from virtual biotechnology companies to the top 10 global pharmaceutical companies.

“I just wanted to say “thank you” for today’s debrief, it’s the best debrief I’ve participated in during my tenure at the company. We really appreciate your thoroughness, expertise and support.”

Director, Global Patient Safety, US Pharma Company

“The Mock inspection was ‘perfect’ a good experience that helped us prepare for the ‘real thing’. It was as real as possible.”

Head of Pharmacovigilance, Global Pharma Company

Contact Us

If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.

Contact Adamas
The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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