Quality Management Systems

Our QMS Consultancy is aimed at optimising systems to ensure high quality output. Our experienced team will review your existing QMS to identify gaps and work with you on solutions to nullify the deficiencies.

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Assess the effectiveness of your quality management system

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Assess the level of compliance

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Advise on quality and efficiency improvements

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Deconstruction of global clinical operations and organisational structure to assess reasons for delays in workflow processes, poor quality work and communication failures.

Identified gaps and aligned the quality management system across functions. Developed metrics to monitor quality of the output on an ongoing basis, resulting in increased operational efficiency.

Advised company new to the regulated pharma industry on how to develop and implement a fit for purpose QMS

Companies performing clinical development internally are becoming increasingly concerned about whether their systems are working efficiently and are compliant with current regulatory requirements. There have been many changes in clinical trials legislation over recent years which have increased the complexity of clinical development and commanded more resources. One of the challenges companies face is being able to meet regulatory expectations with limited resources, whilst remaining competitive.

The success of a clinical trial, or a positive outcome from a regulatory inspection, is dependent on the effectiveness of the quality system in place.

ADAMAS Consulting has a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies. The Consultants provide valuable input into optimising systems to ensure a high quality output.

Thank you for your time and all the hard work you have put in over the last couple of days. I believe it was very productive and a worthwhile exercise. We are compiling all action points now, thank you for your speedy response and summary. We envisage quite a busy time ahead.

M.I.

Clinical Project Manager, International Research Institute

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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