Analytical Research & Development
At Sai Life Sciences, Analytical Science is the backbone of innovation and trust in drug development. Our Analytical Development function empowers pharmaceutical progress by delivering robust, reproducible, and regulatory-aligned methods that ensure product quality, impurity control, and process understanding across every stage of the drug lifecycle.
From early-phase characterization to late-phase validation, we design analytical strategies that evolve with your molecule, providing the clarity and confidence needed for scale-up, technology transfer, and global regulatory submissions. Our expertise spans: Systematic Method development, Impurity profiling & characterization and Stability assessment.
By combining scientific rigor with regulatory foresight, we deliver phase-appropriate solutions that accelerate development timelines while ensuring compliance. Our analytical methods don’t just measure — they enable informed decisions, reduce risk, and build the foundation for successful commercialization.
Our Capabilities
Method Development & Validation
Development and validation of regulatory-compliant methods for SM/RSM’s, intermediates, and NCE’s/API’s.
Physicochemical Characterization
Structural and material characterization using NMR, HR-MS, GC-MS/MS, LC-MS/MS, pXRD, DSC, TGA, DVS, PSD, PLM with hot stage and PFT.
Stress & Stability Studies
Degradation pathway analysis, shelf-life determination, and retest period assignment.
Analytical QbD
Risk-based method development aligned with ICH and global guidelines to strengthen method robustness and lifecycle reliability.
Regulatory Support
Comprehensive documentation and submission-ready data packages for IND/CTA, NDA/MAA and global filings.
Release & In-Process Testing
Analytical support during process optimization, scale-up, and manufacturing to ensure consistent product quality.
Regulatory Documentation Support
Preparation of analytical sections and data packages for IND/CTA, NDA/MAA, and global filings.
Our Capabilities
Method Development & Validation
Development and validation of regulatory-compliant methods for SM/RSM’s, intermediates, and NCE’s/API’s.
Physicochemical Characterization
Structural and material characterization using NMR, HR-MS, GC-MS/MS, LC-MS/MS, pXRD, DSC, TGA, DVS, PSD, PLM with hot stage and PFT.
Stress & Stability Studies
Degradation pathway analysis, shelf-life determination, and retest period assignment.
Analytical QbD
Risk-based method development aligned with ICH and global guidelines to strengthen method robustness and lifecycle reliability.
Regulatory Support
Comprehensive documentation and submission-ready data packages for IND/CTA, NDA/MAA and global filings.
Release & In-Process Testing
Analytical support during process optimization, scale-up, and manufacturing to ensure consistent product quality.
Regulatory Documentation Support
Preparation of analytical sections and data packages for IND/CTA, NDA/MAA, and global filings.
Facilities & Technical Infrastructure
- Comprehensive analytical instrumentation supporting end-to-end method development, validation, and routine testing, including:
- HPLC and UHPLC
- GC and GC-HS
- Prep-LC, Analytical SFC and Prep-SFC
- LC–MS/MS and GC–MS/MS
- HR-MS
- pXRD
- ICP–MS
- NMR
- TGA, DSC, PLM with hot stage and DVS
- PSD and powder flow tester
- Coulometer KF
- Ion Exchange Chromatography
- Automated sample preparation systems and advanced data management platforms to enhance analytical efficiency and consistency.
- ICH-qualified stability chambers supporting a wide range of stability conditions, with backup capacity to ensure program continuity.
- Integrated LIMS (GMP Labs) and ELN systems compliant with 21 CFR Part 11 to maintain data integrity and traceability.
- Ongoing instrument qualification and analyst training to ensure consistent, reproducible analytical outcomes across programs.
Frequently Asked Questions
Sai Life Sciences supports method development and validation through a phase-appropriate, fit-for-purpose Quality by Design (QbD) approach aligned with global regulatory guidelines.
The Analytical R&D team develops robust, accurate, and reproducible methods using techniques such as HPLC/UPLC, GC, ion chromatography, and advanced detection systems. Method development is performed in a GLP environment, and validation activities are executed under GMP conditions within Quality Control.
Data integrity and regulatory compliance are maintained through a structured quality governance framework and integrated digital systems. Operations align with USFDA, EU, TGA, ICH guidelines, and 21 CFR Part 11 requirements.
Scientific Data Management Systems (SDMS) support real-time instrument integration, secure data storage, and archival in a paperless environment. Information security policies safeguard data confidentiality, integrity, and availability in compliance with ISO 27001:2022 and applicable legal and regulatory requirements.
Sai Life Sciences conducts forced degradation studies as part of its analytical services but does not offer extractable and leachable testing.
Forced degradation studies are performed in accordance with ICH guidelines to evaluate stability indicating nature of the method, stability and degradation pathways of drug substances and products under stress conditions, including heat, light, oxidation, and pH extremes.
Yes. Sai Life Sciences supports method transfer and troubleshooting during scale-up to maintain analytical consistency across development phases.
The Quality Control team prepares detailed transfer protocols in coordination with Analytical R&D, aligned with ICH and client-specific requirements. These protocols define method parameters, acceptance criteria, and risk considerations.
During scale-up, on-site or remote support is provided to address issues such as matrix effects, sensitivity variation, or instrument performance differences, ensuring continuity from laboratory to kilo lab or commercial plant while maintaining data integrity and compliance.