Services
Formulation Development
  • Literature Search and Technical Patent Review
  • Pre-Formulation Development
  • Drug-Excipient Compatibility Studies
  • Formulation Development and Optimization
  • Process Development and Optimization
  • Scale-Up and Technology Transfer
  • Process Validation Studies
  • Packaging Development Studies
Analytical Development
  • Analytical Method Development for Assay, Content Uniformity, Related Substances, Dissolution etc.
  • Analytical Method Validation
  • Forced Degradation Studies
  • Method and Site Transfers
  • Specification Development
  • ICH Stability Studies and Stability Sample Analysis
  • R&D Sample Analysis
Quality and Regulatory
  • CTD Filings
  • Dossiers Meeting Various Global Requirements
  • IND / NDA and ANDA Support Documentation
  • Post Approval Changes and Related Regulatory Filings
  • Licensing
Other
  • Contract ICH Stability
  • Vendor Development and Qualification
  • Quality Auditing
  • Quality Services
  • Sourcing Services
  • Portfolio Management Services