Regulatory Services

Preparation of chemistry, manufacturing, and controls (CMC) documentation for drug substances and finished formulations Preparation of Clinical and Non Clinical (Overviews & Summaries), Study Reports, Protocols and others To Prepare, Compile, & Submit DMFs & Dossiers (Investigational Medical Product Dossier (IMPD) / Investigational new drug (IND) applications, NDAs and Generics for various countries Preparation and Submission of Annual Reports, Variation Applications, Renewal Application, Amendments and Supplements Briefing Documents Response to queries from Regulatory Authorities Life Cycle Management

Development of patent non infringing / stable and bio-equivalent products.

At-a-glance: Pre-submission Service:

  • Regulatory Affairs support (CTAs, IMPDs, INDs, NDAs, MAA, global registration submission)
  • CMC Authorship (CTAs, IMPDs, INDs, NDAs, MAA, global registration submissions)
  • Regulatory Affairs and CMC strategic guidance
  • Publishing support – all submission types and format, and reports
  • Regulatory Intelligence
  • DMFs
  • EDQM Certificate of Suitability applications
  • Stability data assessments

At-a-glance: The Post-Submission Service:

  • Regulatory Affairs support across the lifecycle (variations, renewals, annual reports)
  • CMC Authorship across the lifecycle (variations, renewals, annual reports)
  • Regulatory Affairs and CMC strategic guidance
  • Publishing support – all submission types and format, and reports
  • Labeling
  • Regulatory Intelligence
  • Site rationalization regulatory support
  • Stability Data Assessments
  • CTD Conversions (content and format)
  • Clinical Trial support for Clinical Development, Bioavailability & Bioequivalence studies activity

Countries we serve

  • Abbreviated New Drug Application (ANDA) - US
  • European Union Registration - EU
  • Agencia Nationale Vigilenca de Sanitaria (ANVISA) - Brazil
  • Medicines & Healthcare Products Regulatory Agency (MHRA) - UK
  • Therapeutic Goods Administration (TGA) - Australia
  • Medicines Control Council (MCC) - South Africa
  • Commonwealth of Independent States (CIS) Registration
  • Registration in all other Regions across the globe