200+

Regulatory Dossiers Filed

500+

Products in Portfolio

30+

Countries Served

Quality Assurance

Quality at Every Step

Our Quality Management team works to ensure that every product consistently meets internationally accepted standards of purity, safety, and performance. Supported by a strong Quality Assurance framework, we implement the latest ICH guidelines, maintain robust Good Manufacturing Practices (GMPs), Good Laboratory Practices and Standard Operating Procedures (SOPs) and conduct regular internal and external audits to ensure continuous compliance.

  • Globally aligned processes with rigorous testing and validation
  • Precision and scalability at every production stage
  • Product reliability and adherence to stringent regulatory standards
  • Regular internal and external GMP audits for continuous compliance
Full compliance with IP, BP, USP, and EP pharmacopoeial standards
ICH-aligned method development, validation, and documentation
Regular internal and external GMP audits for continuous compliance
Comprehensive batch release testing before every product shipment
Validated analytical instruments calibrated to international standards
Robust deviation management, CAPA, and change control systems

Core Testing Capabilities

Three Pillars of Quality Excellence

Our quality testing capabilities span the full spectrum of pharmaceutical product evaluation, from chemical identity and potency to microbiological safety and long-term stability.

Analytical Testing

Comprehensive physico-chemical analysis of raw materials, in-process samples, and finished pharmaceutical products using validated, internationally recognised methodologies.

  • HPLC, UV-Vis spectrophotometry, and dissolution testing
  • Assay determination and related substances profiling
  • Method development and validation to ICH Q2(R1)
  • IP, BP, USP, and EP compliance testing
  • Raw material identification and purity assessment

Microbiological Testing

Rigorous sterility and safety testing across all dosage forms, with dedicated infrastructure for aseptic manufacturing controls and pathogen detection to the highest international standards.

  • Sterility testing and environmental monitoring
  • Bioburden determination and pathogen screening
  • Endotoxin (LAL) testing for injectable products
  • Microbial limit testing per pharmacopoeial standards
  • Water quality testing and monitoring programs

Stability Studies

Scientifically designed real-time and accelerated stability programmes ensuring product integrity, accurate shelf-life determination, and compliance with global regulatory submission requirements.

  • Real-time and accelerated stability per ICH Q1A(R2)
  • Climatic zone-specific testing (Zones I, II, III, IVa, IVb)
  • Photo-stability and stress testing
  • Shelf-life and retest period determination
  • Packaging compatibility and closure integrity

US FDA
Accredited
WHO-cGMP
Certified
EU GMP
Compliant
PIC/S
Aligned
ICH
Guidelines
IP / BP / USP
Pharmacopoeial