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