DRUG MASTER FILE (US-FDA)
DRUG MASTER FILE (US-FDA SUBMISSION)...
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POST APPROVAL
Once approval has been obtained, there is usually a need for variations on the original marketing authorisation...
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Medical Devices
Classification of medical device, preparation of technical master file, Clinical and non-clical expert report of medical device and in vitro diagnostic....
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DUE DILIGENCE
Are you contemplating a licensing deal, a strategic partnership or a merger & acquisition...
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QMS/cGMP Audit Preparation and Establishment
QMS/cGMP Audit Preparation and Establishment for Pharmaceutical/Neutraceuticals/Herbal/Medical device/Excipients/Drug Substance company GAP analysis, System establishment, Facilitation of Regulatory Agency Audit, Deficiency response (Agency) etc,...
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