• 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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  • PHARMACOVIGILANCE

    Pharmacovigilance system (INDIA)...

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