RESEARCH TRIANGLE PARK, N.C., March 31, 2015 /PRNewswire/ -- Dr. Renu Razdan of leading Indian CRO Max Neeman International, will be attending the World Orphan Drug Congress in April to discuss the latest, progressive announcement regarding India’s regulatory approval process and orphan drugs below:
India’s Drugs Technical Advisory Board (DTAB) has recommended to the Ministry of Health that if a new drug is approved and marketed in a well-regulated country, marketing authorization can be obtained in India with waiver of clinical trial in Indian population. Waiver will be granted if safety efficacy and need of the drug are found favorable and the plan for post marketing surveillance of the drug in the country is approved.
The Ministry decided that such a wavier can only be considered in cases of emergency, extreme urgency and for orphan drugs or drugs indicated for conditions/diseases with no therapy option.
Max Neeman has an established team specialized in carrying out orphan drug trials in response to sponsor need as drug development has been limited by unavailability of subjects, and the high cost of investing in a novel pharmaceutical agent with poor market potential.
The team, having conducted over 15 orphan drug studies in various indications including Hemophilia, Von-Willebrand and Lysosomal storage disorders, has the required expertise to develop innovative approaches to optimize complex study design. Often strict inclusion/exclusion criteria and data analysis for rare disease studies create the greatest challenge for Biotech and Pharma that Max Neeman’s expertise can address.
India has evolved into a preferred destination for conducting Orphan drug trials because of cost-effective and faster patient recruitment supported by the country’s diverse gene pool and vast population of 1.3B.
Max Neeman International conducts India-based clinical research services for clients across the globe delivering quality results and exceptional customer service resulting in high client satisfaction.
About Max Neeman International
Max Neeman International is a full service CRO with India expertise. We offer services for the successful conduct of clinical trials for small and mid-sized drug, device and nutraceutical companies in compliance with ICH GCP standards. Max Neeman is ISO certified for Monitoring, Site Management, Medical Device and Data Management services. Please Contact Ann Vawter, Director of Business & Marketing via email to ann.vawter@neeman-medical.com or call +1.919.424.3332. www.neeman-medical.com
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