Services

Clinical Trial Material Services

  • Packaging, Labeling and Worldwide Distribution
  • Inventory Management
  • Returns, Accountability and Destruction

Topical Formulation Development Services

  • Preformulation – Solubility, Excipient Compatibility and pH Profile
  • Formulation Development and Optimization
  • R&D Stability Evaluation
  • Container/Closure Selection (Compatibility Testing)
  • Process Development
  • Quality by Design (QbD)
  • Formulation Development Report

Manufacturing Services

  • Small-Scale GLP and GMP Manufacturing and Packaging
  • Process Scale-Up Planning
  • Technical Transfer Support

Analytical Services

  • API and Drug Product Method Transfer and Qualification
  • Analytical Method Development/Validation
  • In-Process and Finished Product Release Testing
  • Identification and Quantification of Impurities/Degradation Products
  • Photodegradation Studies
  • In Vitro Release Studies

Stability Services

  • ICH Stability Storage and Testing
  • Stability Tables/Reports

Regulatory Support

  • Product Development Strategies
  • IND/NDA Preparation and Submissions
  • IND/NDA Maintenance (Amendments, Protocol Amendments, Annual Reports, etc.)
  • FDA Correspondence