Analytical development (AD) includes reverse engineering, method development, method validations, routine analysis and stability studies and supports our formulation development activities. The AD teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities.
Analytical services
- Analytical Method Development for Assay, Content UnifRelated Substances, Dissolution etc.
- Analytical Method Validation
- Analytical Method Qualification
- Forced Degradation Studies
- Method and Site Transfers
- Specification Development
- ICH Stability Studies and Stability Sample Analysis
- R&D Sample Analysis.
- HPLCs with photodiode array detectors
- HPLCs with UV detectors
- UV Spectrometer
- FT-IR (A Fourier Transform Infrared) spectrometer
- NMR (Nuclear Magnetic Resonance)
- Potentiometer
- Dissolution apparatus with Auto sampler
- CTD Filings
- Dossiers Meeting Various Global Requirements
- IND / NDA and ANDA Support Documentation
- Post Approval Changes and Related Regulatory Filings
- Licensing