Our extensively equipped laboratories are designed to respond to the increasing demand for quality control and batch release testing by a third party laboratory.

Instrumentation comprises:

• 8 GC systems, with a wide range of detectors
• 7 HPLC
• 2 UV / Vis Spectrophotometers
• 2 AA Spectrophotometers
• TOC & Conductivity Analysers
• GPC
• GCMS
• 3 Dissolution Baths
• Walk-in Storage Stability Room
• Various Storage Stability cabinets

With extensive experience in Method Development, Validation and Transfer, the laboratories are MCA approved for GMP compliance and offer a complete range of Pharmacopoeia testing covering Raw Materials, Intermediaries and Finished Products including:

• Tablet, Suppository & Pessary testing
• Residual Ethylene Oxide, Glycol & Chlorhydrin
• Uniformity of Content
• Drug Purity
• Active Ingredients Content
• Related Substances
• Storage Stability Trials to ICH Guidelines (Storage with analysis only)
• WFI & Purified Waters for TOC, Conductivity, Heavy Metals & Nitrates

Regulatory Assistance

This services covers the testing requirements for the registration of Pharmaceutical products in conjunction with preparing regulatory submissions, including:

• Advice on data requirements
• Consultation with regulatory authorities for advice on studies
• Co-ordination of searches for published safety & efficacy data and it’s scientific evaluation
• Advice on applications for Marketing Authorisation