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India's Favorable and Progressive Regulatory Environment Causes Accelerated Growth of Max Neeman International's Regulatory Services
Date:10/11/2010

RESEARCH TRIANGLE PARK, N.C., Oct. 11 /PRNewswire/ -- India has evolved into a preferred destination for conducting clinical trials in large part because the Indian Regulatory bodies have created an environment which is focused on quality, transparency and protection in research activities.  Regulatory standards meet the requirements of ICH GCP, ICMR (Indian Council of Medical Research) and all the other regulatory bodies across the globe.

Owing to the favorable regulatory environment in India, Max Neeman's regulatory services have grown tremendously over the past few years and team members are qualified with more than 5 years of regulatory experience.  They specialize in providing the most effective regulatory assessment and strategy for timely submission and early approval. A systematic approach, rigorous follow-up and dedicated resources provide regulatory solutions for successful completion of the drug development cycle for clients.

The main regulatory body of India's government overseeing clinical trial research is the Drug Controller of India, Ministry of Health and Family Welfare, Government of India (DCGI).  DCGI is similar to the United States FDA who opened only the second non-USA office in India in 2009.  The Max Neeman team is updated with the all the recent and upcoming regulatory reforms initiated by the regulatory bodies in India and has the relationships to liaise with them effectively.

Based on each client's requirements, the regulatory team helps in developing:

  • regulatory strategy per client's requirements
  • regulatory submission and approval for initiating the trial
  • a review and evaluation of the pre-clinical data to provide step wise assistance in responding to questions by a regulatory body

Max Neeman will continue to maintain a strong regulatory team in support of India's progressive regulatory environment and th
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SOURCE Max Neeman International
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