Advancing Molecules. Enabling Medicines.
Where Scientific Innovation Meets Scalable Pharmaceutical Solutions.
Analytical Research & development
Our Analytical Research & Development (AR&D) function supports complete product lifecycle—from early development to commercialization. Working in close collaboration with R&D, manufacturing & QC teams, AR&D ensures strong analytical understanding and robust control strategies to support consistent globally acceptable product quality.
Core Responsibilities
AR&D’s core responsibilities include specification finalization in alignment with ICH guidelines, analytical method development, validation, and transfer to Quality Control (QC), and comprehensive impurity profiling, including genotoxic and nitrosamine impurities.The team also supports pharmacopeial method verification, specification alignment, and timely responses to regulatory submissions and queries.
Pharmacopoeial Alignment
AR & D actively supports pharmacopeial alignment and monograph development, coordinating with global agencies such as EDQM and USP. All activities are conducted within a digitally enabled, data-integrity-compliant quality framework, ensuring traceability, reliability, and audit readiness across the development lifecycle.
Quality Control
Our Quality Control (QC) function operates as an independent and critical compliance unit, ensuring the quality, safety, and conformity of raw materials, intermediates, APIs, and finished products prior to batch release.
The QC laboratories are equipped with modern, validated analytical systems, including XRD, HPLC/UFLC, GC, FTIR, UV–Visible spectrophotometers, LC–MS, and particle size analysers, supported by a dedicated microbiology laboratory. All critical analytical instruments and computerized systems are 21 CFR Part 11–compliant, ensuring secure data generation, processing, and storage.
All QC activities are conducted in strict accordance with cGLP requirements and are fully integrated with a validated Electronic Quality Management System (eQMS) and chromatography data systems, ensuring data integrity, traceability, audit readiness, and full regulatory compliance for every batch released.
Analytical Laboratories & Capabilities
Our laboratories are equipped with modern, validated analytical systems, including XRD,
HPLC/UFLC, GC, FTIR, UV–Visible spectrophotometers, LC–MS, and particle size analysers, supported by a dedicated microbiology laboratory. All critical analytical instruments and computerized systems are 21 CFR Part 11–compliant, ensuring secure data generation, processing, and storage.
- XRD
- HPLC/UFLC
- GC
- UV visible spectophotometers
- FTIR
- LC-MS
- Particle size analysers
- Support Robust
Systems Integration & Digital Quality
All QC activities are conducted in strict accordance with cGLP requirements and are fully integrated with a validated Electronic Quality Management System (eQMS) and chromatography data systems, ensuring data integrity, traceability, audit readiness, and full regulatory compliance for every batch released
- XRD
- HPLC/UFLC
- GC
- UV visible spectophotometers
- FTIR
- LC-MS
- Particle size analysers
- Support Robust