Regulatory-Affairs

GSS Pharma Private Limited enables the Pharmaceutical companies understand the regulatory requirements and thus extends its service to the companies in launching their products in the competitive market.

The Regulatory Affairs professionals at GSS Pharma Private Limited ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws. The team extends its support in providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans. The team plays a major role in advising the companies on regulatory aspects and climate that would affect their proposed activities.

  • 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