Regulatory Affairs

Regulatory Affairs:

We provide tailored services and submission to our sponsors/Clients and execute project plans to meet diverse regulatory requirements of clinical trials development.

In the clinical trial development, the regulatory start-up phase is the first and most important step to get Drugs Controller General of India (DCGI) Approval letter from our respected national regulatory body Central Drugs Standard Control Organisation (CDSCO). we avoid potential delays when managing sponsors' projects.

(CDSCO) serves a similar function to the European Medicines Agency of the European Union,the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and theMedicines and the Medicines and Healthcare Products Regulatory Agency of the United
Kingdom.

CDSCO Has 8 Divisions:

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BA/BE

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New Drugs.

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Medical Device & Diagnostics.

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DCC-DTAB.

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Import & Registration.

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Biological.

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Cosmetics.

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Clinical Trial

Our Tailored Services Include: