Presentation: FDA Requirements for Investigation New Drug (IND) in USA

Reviewed Topics:

  • What is an IND?
  • What are the IND Phases?
  • What is the IND content?
  • FDA timelines for IND review?
  • What studies are exempt from IND?
  • cGMP requirement?


Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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