Advanced Analytical Solutions (AAS) provides high-end analytical services that support every stage of drug development, from discovery to commercial manufacturing. The function ensures data reliability, method robustness, and compliance with global regulatory standards, enabling confident decision-making throughout the API lifecycle.
Key Deliverables
- Analytical Method Development & Validation: Creating sensitive, robust methods for APIs, intermediates, and impurities.
- Characterization of Molecules: Structural elucidation using NMR, MS, IR, UV, and other spectroscopic techniques.
- Impurity Profiling & Quantification: Identification and quantification of related substances and degradants.
- Stability Studies & Forced Degradation Testing: Assessing API and formulation stability under ICH conditions.
- Support for Regulatory Submissions: Preparing analytical sections for IND, NDA, ANDA, and DMF filings.
- High-throughput and Automated Analysis: Enabling rapid screening and data generation for accelerated timelines.