GPRC Solves your CMC puzzle.



Regulatory Support

Compile CMC section of the ANDA, NDA and IND application to seek US-FDA approval.
Categorize and file the post approval changes to facilitate FDA approval. 
File the applications in paper, CTD and eCTD formats
Click here for Regulatory Support


Product Development Support

 Develop new formulation and mfg process and also trouble-shoot the approved formulation or manufacturing process under SUPAC guidance. 
Technology transfer, scale-up and process validation.
Click here for Product Development Support


Generic Pharma Regulatory Consultants


 We can help with your Regulatory Submissions.


We can serve as your US agent for FDA and/or serve as liaison between US FDA and your company.


 We can help you resolving the formulation and manufacturing process issues.