Mock Regulatory Inspections

Our former Regulatory Authority inspectors are able to conduct realistic mock inspections to test the robustness of your systems and to prepare your staff for the real thing. We help companies through successful GCP and GVP inspections in many different countries.

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Inspection preparation training

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Inspection co-ordination and management

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Optimising responses to inspection findings

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Identified critical and major findings whilst preparing two sites for FDA inspections. Worked with sites and sponsor to put CAPA in place. During the FDA inspection one site received an FDA 483, whilst the other site had NAI.  ADAMAS subsequently helped the site with their responses to the FDA 483, which were accepted by the FDA.

Conducted inspection readiness at investigator site and facilitated FDA inspection. The inspection outcome was NAI and the drug was subsequently approved by the FDA.

Pre-inspection training including planning and organisation, roles and responsibilities of staff and mock interviews

Many organisations are preparing themselves for GCP and Pharmacovigilance inspections. ADAMAS Consulting has the team, the skills and the experience to conduct Mock GCP and Pharmacovigilance Inspections according to your needs.

This may include, but is not limited to, the following:

  • Gap Analysis
  • Identifying and prioitising improvements
  • Corrective Action Support
  • Training – ‘Preparing for Inspection’
  • Preparing a War Room
  • Mock Inspection
  • Hosting the Inspection
  • Inspection interview training
  • Preparing Sites for Inspection

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

S.J.

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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