Regulatory Affairs Services
   Provide regulatory support to develop efficient and effective strategies for the submission of new and supplemental applications including scale up and post approval changes (SUPAC) and facilitates drug approval process.

 Compile chemistry, manufacturing and control (CMC) section of the ANDA, NDA and IND application to seek US-FDA approval.

  Categorize, compile and file the post approval changes and amendments to facilitate FDA approval.

   We specialize in:


 Prepare, compile and summarize the application in Common Technical Document (CTD) format for filing the application to US-FDA either in paper CTD or electronic CTD (eCTD) formats including SPL.

  Represent our clients and communicate with FDA and also act as liaison between FDA and the client company.

 Support generating in-house regulatory policies and procedures, SOPs.

 Support registration of drug establishment/labeler code assignment and drug product listing.