Precision Testing at Every Stage
Our QC laboratories operate under validated systems ensuring all raw materials, intermediates, and finished APIs meet predefined specifications before release — guaranteeing safety, efficacy, and consistency.
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Raw Material, Intermediate & Finished Product Testing Complete analytical testing at every stage of production lifecycle
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Analytical Method Development & Validation ICH-compliant methods developed and validated for accuracy & reproducibility
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Stability Studies as per ICH Guidelines Long-term and accelerated stability programs per ICH Q2 (R1)
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Environmental Monitoring & Water Analysis Continuous monitoring of cleanroom environments and purified water systems
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Reference Standards & Retention Sample Management Systematic archival and lifecycle management of all reference materials
Our Quality Pillars
Built on a foundation of regulatory excellence, analytical precision, and a culture of continuous improvement
Global cGMP Compliance
Fully aligned with ICH, WHO-GMP, FDA, MFDS, c-GMP, c-GLP, ANVISA and pharmacopoeial standards (IP, BP, USP, EP, IH) ensuring seamless global market acceptance.
Advanced Analytical Labs
State-of-the-art instrumentation including HPLC, GC, FTIR, UV-VIS, and stability chambers delivering high precision and validated results.
Data Integrity & ALCOA+
Strict adherence to ALCOA+ principles ensuring all data is attributable, legible, contemporaneous, original, accurate, and audit-ready.
Built on Validated Systems
Our QC laboratories ensure all raw materials, intermediates, and finished APIs meet predefined specifications before release — guaranteeing safety, efficacy, and consistency.
- In-Process Quality Checks
- Out-of-Specification (OOS) Investigation
- Calibration & Qualification Program
- Batch Record Review & Release
- End-to-end data integrity per ALCOA+
Quality Control
Our Quality Control laboratories operate under validated systems to ensure that all raw materials, intermediates, and finished APIs meet predefined specifications before release — ensuring safety, efficacy, and consistency.
World-Class Testing Infrastructure
Each department is equipped with validated, state-of-the-art instruments ensuring precise, reproducible, and globally compliant analytical results
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HPLC — High Performance Liquid Chromatography
Our HPLC laboratory is the backbone of API identification and purity profiling. Equipped with cutting-edge systems, we achieve precise quantification of active ingredients, related substances, and degradation products.
- Assay and purity testing for API batches
- Related substances and impurity profiling
- Validated method as per USP, BP, EP, IP, IH
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GC & GC Headspace Analysis
Our Gas Chromatography and GC Headspace systems are dedicated to residual solvent testing and volatile impurity detection. Fully compliant with ICH Q3C guidelines, these systems safeguard API quality at the molecular level.
- Organic volatile impurities (OVI) testing per ICH Q3C
- GC Headspace for Class I, II & III solvents
- Validated method as per in-house
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Spectroscopy — FTIR & UV-VIS
Fourier Transform Infrared (FTIR) and UV-Visible spectroscopy form our identity confirmation and quantitative analysis powerhouse — providing rapid, non-destructive structural fingerprinting of every API batch.
- FTIR for structural identity
- UV-VIS for quantitative absorbance measurement
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Chemical Analytical Laboratory
Our Chemical Analytical Lab specialises in physical property characterisation — ensuring APIs meet stringent particle size, density, and flowability specifications critical for downstream formulation success.
- pH, Melting Point, TLC, Auto-titrator Analysis
- Bulk density and tapped density determination
- Sieve shaker analysis for Particle size distribution
- Loss on drying (LOD) and moisture content
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Microbiology Department
Our dedicated Microbiology Department operates in a controlled cleanroom environment, ensuring every API batch is free from microbial contamination and meets the highest standards of pharmaceutical purity.
- Total microbial count (TAMC & TYMC)
- Bioburden testing and trend analysis
- Environmental monitoring program
- Purified water and WFI microbial testing
- Identification of specified organisms (E. coli, Salmonella, etc.)
Quality Built Into Every Process
Our QA system proactively ensures compliance, risk mitigation, and continuous improvement at every stage of manufacturing
Robust Quality Management System
A comprehensive QMS governing all manufacturing operations, documentation, training, and continuous improvement activities aligned with global cGMP requirements.
Deviation Handling, Change Control & CAPA
Systematic management of deviations, change control workflows, and corrective/preventive action systems ensuring quality events are resolved and prevented.
Internal Audits & Regulatory Readiness
Regular internal audit programs and mock inspections ensure we remain perpetually inspection-ready for WHO, MFDS, ANVISA, and other regulatory authorities.
Vendor Qualification & Material Traceability
Rigorous supplier qualification processes and end-to-end material traceability systems ensuring the integrity and compliance of every incoming component.
Training Programs & Compliance Culture
Ongoing GMP training, competency assessments, and a culture of quality ownership ensure every team member contributes to maintaining the highest standards of pharmaceutical excellence.
Global Certifications and Regulatory Approvals
Our facilities and quality systems are recognised by international regulatory authorities, reflecting our commitment to compliance, transparency, and global market readiness
Have a Quality or Compliance Query?
Speak directly with our Quality team about API specifications, regulatory dossiers, audit arrangements, or any compliance enquiries. We respond within 24 hours.