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 | Regulatory Service » Indian Regulatory |
The Regulatory Affairs Department at Max Neeman is geared to provide the most effective regulatory assessment and strategy for timely submission and early approval.
The key advantages offered by Max Neeman’s regulatory services include:
- Clinical Trial permission from Drugs Controller General (India), Ministry of Health and Family Welfare, Government of India.
- Permission to import clinical trial material from Drugs Controller General (India), Ministry of Health and Family Welfare, Government of India.
- Permission to export clinical study related human biological samples for their analysis from Directorate General of Foreign Trade, Ministry of Commerce, Government of India.
- License to export clinical study related human biological samples for their analysis from Joint Directorate General of Foreign Trade, Ministry of Commerce, Government of India.
INDIA'S PROGRESSIVE REGULATORY ENVIRONMENT
India offers a progressive regulatory environment focused on quality,transparency and protection in research activities.
Indeed, Indian based regulatory bodies cooperate fully with international regulatory agencies to ensure its regulatory standards meet the requirements of the U.S. FDA, and ICH GCP guidelines. A recent result of international cooperation, added to the increase in clinical trials from India, is for the U.S. FDA to establish a liaison offi ce in India, in 2009.
Indian regulatory bodies are committed to progressive review and approval of foreign clinical
research requests. The Max Neeman Group maintains a strong regulatory team that supports our clients in all regulatory aspects.
Regulatory Bodies
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- Ministry of Health Approval:
Drug Controller General of India (DCGI) for permission to conduct trial & import license
- Ethics Committee Approval:
Simultanious submissions of Ministry of Health and E.C. Dossier(s)
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Recent introduction includes that of ‘category A’ clinical classification which fast tracks those drug and protocol combinations that have been previously approved in the U.S., UK, Germany, Japan and other countries yielding DCGI expedited approval.
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