Analytical
Solutions
under cGMP
conditions

Accelerating your product development efforts with quick turnaround time, with emphasis on quality, safety and, compliance

GVK BIO has rich expertise and experience in supporting clients with analytical testing services under cGMP for all kinds of analytical packages like method development, method validations, stability studies on exhibit, registration, follow up batches, solid state characterization, extractable studies, leachable studies and quality control / batch release testing complying to regulatory requirements across the globe.

Salient features:

  • Inspected by US FDA with ZERO 483’s
  • ISO 17025 (NABL) accredited
  • Works on Fee-for-Service (FFS) or Full-time equivalent (FTE) business model approach
  • State-of-the art and GMP compliant facility
  • Highly qualified team of professionals to accomplish tasks and help customers

GVK BIO offers a wide range of cGMP analytical solutions to meet the complex challenges faced during the research process. Our services are as below but not limited to:

Solutions we offer

  • Analytical method development
  • Analytical method validations
  • Stability studies including photo stability
  • In use stability studies and freeze-thaw cycles
  • Drug-excipient compatibility studies
  • Batch release testing
  • Solid state characterization, validation and release
  • Polymorphic screening and quantification
  • Physicochemical characterization
  • Impurity profiling
  • Genotoxic impurity analysis and metals testing
  • Extractable and leachable studies
  • Glass delamination studies
  • Microbiology limit tests, sterility, bacterial endotoxin test, preservative efficacy test

Brochure

Formulation & Analytical Solutions

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Whitepaper

Developability Assessment of Small Molecules

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