Services
- 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 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
- CTD Filings
- Dossiers Meeting Various Global Requirements
- IND / NDA and ANDA Support Documentation
- Post Approval Changes and Related Regulatory Filings
- Licensing
- Contract ICH Stability
- Vendor Development and Qualification
- Quality Auditing
- Quality Services
- Sourcing Services
- Portfolio Management Services
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