Our Services

To provide industry-leading expertise, progressive strategy, consistent performance, and services customised specifically to the needs of each of clients and customers.

  • Regulatory Affairs and Product Development
  • Dossier GAP Analysis
  • CMC Strategic Guidance
  • Regulatory Documentation Management
  • Publishing and Submissions
  • Life Cycle Management
  • Regulatory Information Management
  • Product Registration support: NDAs, ANDAs, MAA and other global registration applications
  • PMA, 510K, CE , IFU’s, IDEs, CERs and CEPs for Medical Devices
  • BLA Support for Biologicals
  • Product Development and CMC Strategic Guidance
  • Quality Summarisations and Documentation Management
  • Publishing Support: Paper, NeeS and eCTD
  • CTD conversions: Content and Format
  • Territory Specific Site Registration Applications
  • Life Cycle Management: Variations, Renewals, Annual reports
  • Supporting API manufacturers with CEP Applications
  • Regulatory Information Management
  • Submission support: CESP, e-Submission platform and Gateways
  • Conduct face-to-face Meetings with Regulatory Authorities: MHRA and other EU Countries

Have a business query? Connect with us.

We would be very happy to answer any questions you may have. Contact us and discuss your business objectives.

Email: sales@gsspharma.com  | bd@gsspharma.com –   Call+91-80 4951 4937 | +91-80 4956 5668