Navigation Links
India's Favorable and Progressive Regulatory Environment Causes Accelerated Growth of Max Neeman International's Regulatory Services

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 the client's needs.

About Max Neeman International

Max Neeman International is a leading India-based CRO. Our specialty is that we offer services for the successful conduct of Phase I-IV clinical trials for small and mid-sized international and national Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in compliance with ICH GCP standards. Operational since 2001, Max Neeman is an ISO 9001:2008 certified CRO for Monitoring, Site Management and Data Management Services. The company is presently active in over 31 cities with 6 regional offices.  Contact Donald Swankie, Vice President of Business Development via email to or call +1.919.424.3345.  For more information please visit

SOURCE Max Neeman International
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKlines Candidate Cervical Cancer Vaccine
2. Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer
3. Hospira Receives Favorable Court Decision on Eloxatin(R)
4. Haemonetics Receives Favorable Ruling in Patent Lawsuit against Competitive Technology
5. Interim Analysis of Top-Line Data From Phase II/III Study Shows Favorable Efficacy & Safety for Cortheras Relaxin in Acute Heart Failure
6. Custom NX(R) Drug Eluting Stent System Continues to Demonstrate Favorable Outcomes in Challenging Patient Populations at One, Two and Three Years
7. Bucindolol Significantly Reduces Hospitalization and Death in Heart Failure Patients With Very Favorable Genotypes
8. MedImmune Presents Data Highlighting its Progressive Inflammatory Disease Portfolio at the 72nd Annual Meeting of the American College of Rheumatology
9. OXPEKK-IG Device Viking Gains Regulatory Approval in Korea
10. Stemedica Announces the Appointment of Dr. Csar Amescua Garcia as Medical and Regulatory Affairs Director – Latin America
11. Stemedica Announces the Appointment of Dr. Lev Verkh as Chief Regulatory and Clinical Development Officer
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... International ... and one of the premier annual events for pharmaceutical manufacturing: 2015 Annual Meeting. ... 2015, where ISPE hosted the largest number of attendees in more than a ...
(Date:11/24/2015)... Nov. 24, 2015  Clintrax Global, Inc., a worldwide provider of ... , today announced that the company has set a new quarterly ... quarter on quarter growth posted for Q3 of 2014 to Q3 ... Mexico , with the establishment of an ... --> United Kingdom and ...
(Date:11/24/2015)... PA (PRWEB) , ... November 24, 2015 , ... This ... entrepreneurs at competitive events in five states to develop and pitch their BIG ideas ... projects from each state are competing for votes to win the title of SAP's ...
(Date:11/24/2015)... , November 24, 2015 SHPG ) ... participate in the Piper Jaffray 27 th Annual Healthcare Conference ... December 1, 2015, at 8:30 a.m. EST (1:30 p.m. GMT). ... Chief Financial Officer, will participate in the Piper Jaffray 27 th ... , NY on Tuesday, December 1, 2015, at 8:30 a.m. EST ...
Breaking Biology Technology:
(Date:11/12/2015)... 12, 2015  Arxspan has entered into an ... Harvard for use of its ArxLab cloud-based suite ... The partnership will support the institute,s efforts to ... research information internally and with external collaborators. The ... managing the Institute,s electronic laboratory notebook, compound and ...
(Date:11/10/2015)... NEW YORK , Nov. 10, 2015 /PRNewswire/ ... refers to behavioral biometrics that helps to identify ... prevent fraud. Signature is considered as the secure ... for the identification of a particular individual because ... offers more accurate results especially when dynamic signature ...
(Date:11/2/2015)... PARK, Calif. , Nov. 2, 2015  SRI ... $9 million to provide preclinical development services to the ... the contract, SRI will provide scientific expertise, modern testing ... wide variety of preclinical pharmacology and toxicology studies to ... --> The PREVENT Cancer Drug Development ...
Breaking Biology News(10 mins):