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Contact Us
Europe - Tel: +44 (0)1344 751 210
US and Canada - Tel: +1-951-240-5635
Germany - Tel: +49 7531 9027084


  • Vishakha Damle
    International Quality Consultant

Vishakha has over 18 years experience of GLP and GCP Quality Assurance across sponsor, contractor, and governmental environments. She has conducted numerous clinical site audits within United States as well as many international clinical site audits in several countries including India, Mexico, Canada, Argentina, South Africa, Brazil. She has also performed international vendor qualification audits for clinical laboratories and drug depot distribution centers. Vishakha has strong experience in conducting audits of all phases and aspects of clinical trials. She has conducted GLP and GMP facility audits for compliance with FDA, European, and International Standards. She has a global perspective on clinical QA policies and strategies. She is also fluent in Indian languages. Vishakha has B.S. and M.S. degrees in microbiology and started her career in animal toxicology studies. She moved on to several different roles with increasing responsibilities in quality assurance working with numerous pharmaceutical companies and CROs at a managerial level.

 

“As always, it was a very interesting and enriching experience auditing with you; I really enjoyed our collaboration.“H.B., CQA Manager, Global Pharma