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