Analytical and Research Services

Analytical and Research services is an area in which Bilcare GCS excels. We implement various innovative investigating techniques for evaluating the performance of a formulation. Such critical analytical and research tests often form the basis for future development. Bilcare GCS develops and qualifies a range of analytical methods that are implemented at various phases of drug development and manufacturing. Our analytical and research services are protocol-driven and can be tailored to fulfill specific client needs.

The entire process of testing of materials is supervised by our team of GMP compliant scientists. This ensures that the product is in compliance with the required regulatory standards. We also extend our assistance in form of technical support at every phase of product's development and manufacturing.

Bilcare GCS' comprehensive offering of analytical services for drugs, packaging materials, components and systems includes:

  • HPLC analysis
  • Content uniformity studies
  • Chromatographic impurity profiling
  • Identification testing
  • Performance type testing (e.g. friability, hardness and dissolution testing)
  • Release testing
  • Stability and storage testing
  • Cleaning verification / validation
  • Accelerated drug stressing
  • Dissolution profile testing
  • Extractable studies for parenteral products
  • Competitor analysis for unbiased de-formulation
  • Hygroscopicity studies
  • Method development and validation for all phases and components in development of drug substances, non-compendial excipients and drug products
  • Process development support
  • Reference standard qualification testing
  • Stability study protocol design (ICH and custom)
  • Mapped environmental chambers including 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 25°C/40% RH, 40°C/25% RH, 5°C, and photo stability

Bilcare GCS' Analytical & Research Infrastructure

  • Spectroscopy laboratory
  • Dissolution laboratory
  • Chromatography laboratory
  • Physical testing laboratory
  • Sample preparation laboratory
  • Development laboratories
  • Stability storage suite