Research & Development
Regulatory and Compliance support
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Regulatory and Compliance support

The company possesses Capability for preparing technical Dossiers as required by Individual countries and DMR Our facilities are constantly upgraded to comply with European Inspection making us strategically poised to enter regulated markets adopting hi-tech facility.

Complete compliance to cGMP procedure and record maintenance as per ICH guidelines.

  • Committed Formulation Development Department.
  • Well-equipped Quality Assurance Department ensures stringent maintenance of quality standards.
  • Regulatory Department capable of handling common technical documents and dossiers for any country.

Dossier compilation as per

  • Asean Common Technical Dossier (ACTD) Guidelines.
  • Common Technical Dossier (CTD) Guidelines

Dossiers compilation for submissions in

  • Asia
  • Africa
  • Russia
  • South America
  • Gulf

Drug master file (DMF) compilation for open and closed parts

Drafts data for

  • BMR, MFR
  • Process Validation,
  • Stability Study reports,
  • Dissolution profile,
  • Certificate of analysis and related reports

Reports on

  • Bioavailability / Bioequivalence Studies,
  • Clinical Trials studies
  • Justification for fixed dose combination
  • Prepare Periodic Safety Update report (PSUR).
  • Preclinical studies like Toxicity, Carcinogenicity, and Teratology & Reproduction toxicity.