Analytical Method Development and Validation on API and Final Products
Compatibility on API-Excipients/Package Materials
QC Test including Assay and Impurity, et al
Clean Validation on Equipment and Clean Area
Stability Study in Compliance with ICH Guidance
Analytical Method Development and Validation on PSD Determination

API Physicochemical Properties and Intrinsic Dissolution Study
Formulation Screening by Stability, Dissolution, Pilot BE
Process Selection Based on Physicochemical Properties of the Drug Candidate
Scale-up, Process Parameters Optimization and In-process Control Specifications
Storage Condition and Packaging Evaluation for Development Candidates
Tech Transfer of Formulation and Manufacturing Process

Customized Synthesis of Small Molecules (<1kg)
Develop Alternative Synthesis Route
GMP Process Optimization and Validation
Pilot GMP Batch Manufacturing (Kg Scale)
Commercial GMP Manufacturing (from Kg to Tonnage)
Study on API Stability as per ICH Guidance
Particle Size Reduction and Micronization
Crystal Form Selection and Optimization

DMF/EDMF Compilation and ANDA/IND/NDA Assistance as per CTD Format
DMF/EDMF Submission and Liaison with Worldwide Regulatory Authorities
Pre-approval Inspection and System-based GMP Audit
Regulatory Strategy for Product Development

Global Sourcing
Global Market Development
Sales and Market Development in Selected Fields
Business Development
Client Services