Regulatory Support

20 Years Of Legacy In Impacting
Human Lives Through Excellence
And Innovation

  • Product Development Report
  • Master Formula Record, Master Packing Record, Analytical Method Development, Analytical Method Validation, Analytical Method Transfer, Specification/STP for Drug Substance, Specification/STP for Excipients and Specification/STP for Finished Product (Release/Shelf-life).
  • Executed Validation/Exhibit Batch manufacturing records documents review and support
  • Clinical CROs report review and support
  • Bridging work and Possible Product Extension to Other markets
  • Addressing Product regulatory deficiency, if any
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Expansion of Phase 2 Manufacturing for Small Volume Parenteral“Axxelent R&D unit received Recognition letter & Registration Certificate from DSIR, Ministry of Science and Technology, Govt. of India”