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Regulatory Assistance

"A Consolidated Approach for Regulatory Affairs"

An increasing number of consumers and businesses are choosing safe and environmentally friendly products and manufacturers when making a purchase decision. Health and environmental legislation will require compliance by manufacturers, retailers, brand managers, traders, and distributors across the globe. The right knowledge and inbuilt scientific culture is present within the individuals at ClewAce Solutions. Our regulatory services include:

  • Compilation and submission of various modules of eCTD as well as ACT
  • Active support to different regulatory agency queries within the stipulated time
  • Drafting of regulatory submissions as per regulatory requirements for various global markets
  • Prepare and submit supplements, annual reports and other documents to USFDA
  • Critical undertaking of all legal activities guidance to DCGI including Form 11, From 29, NOC from 29, Procurement NOC, MD-16(Medical device), Export NOC, LFDA, From 10, COPP for various sites
  • Solving regulatory query
  • Guidance for DCGI filing
  • GAP analysis for regulatory audit
  • Preparation and review of quality documents
  • Review of Protocols, Reports
  • Stringent Framework of SOPs
  • Review of Critical Documents i.e. MBR/BMR
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