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   News & Events

28th Feb 2012: Sanhar is leveraged with Regional specific Regulatory Submission expertise and be able to help the customers in Multi Geographical Regulatory Submissions.

20th Feb 2012: Sanhar is an Associate Member of Indian Drug Manufacturers Association (IDMA), enabled with a gateway to reach out to more Domestic Customers now.

06th Jan 2012: Sanhar Joins hands with “Registrar Corp”, an U.S. based company to leverage its Regulatory Consulting services pertaining to the U.S. FDA Registration related Businesses.

 
 
 
 
   Regulatory Affairs Consulting
 

SANHAR’s Regulatory Affairs Consulting team is up to date with current Regulatory requirements, Interpretation of Global Regulations, Guidance and Industry trends. The global regulatory environment is changing rapidly to address the technological and scientific advancements. The regulatory experts are finding it difficult to keep pace with the continually changing environment of the Life Sciences Industry. Life Sciences companies must respond quickly to the changes in global regulatory requirements. There are regional specific regulations which are making the processes very difficult to handle multiple geographies to get regulatory approval for marketing the drugs to different countries. As the Industry is moving towards globalization, there are initiatives happening to harmonize and streamline regulatory processes across multiple geographies. The recent initiative by the Regulatory authorities such as USFDA, EMA and TGA to collaborate in order to jointly inspect Active Pharmaceutical Ingredient manufacturers and focus towards Good Clinical Practices to ensure Product Quality and Patient Safety is a good step towards Globalization.

 
   We provide the following consulting services to the Life Sciences customers.  
 
  • Establishing Global Regulatory Strategy
  • Regulatory Submission Processes
  • Business Process Optimization for the entire Pharmaceutical Product Life Cycle
  • Post Merger & Acquisition Integration Strategies
  • Establishing Quality Management System
  • Harmonization of standards for better regulatory compliance
  • Technology Transfer Processes 
  • GxP Compliance
 
 
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