The Ministry of Health and Family Welfare, India, has granted approval to making the accreditation of Ethics Committees (ECs), involved in supervision of clinical trials, mandatory with effect from 01-Jan-18.

The National Accreditation Board for Hospitals & Healthcare Providers (NABH) (http://nabh.co/Index.aspx) has started accepting applications from ECs for accreditation (http://nabh.co/Announcement/CTNotice.pdf).

The NABH has also announced a training programme on implementation of NABH Accreditation of Clinical Trial (ECs), in nine major cities in India from April to December 2017. The first training program will be conducted in Mumbai on 28 to 29-Apr-17. The event details can be found on http://nabh.co/EventDetailsPopup.aspx?id=212

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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