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Pharmaceutical Process Validation

Drug Research And Development

We have been providing pharmaceutical intermediates and API development services for nearly three decades to clients from our network of R&D as well as manufacturing facilities across the globe.  Our synergistic model of delivery across Canada, India and the UK offers the advantages of speedy drug development, proximity to markets as well as flexible solutions.  We have a team of over a hundred scientists across geographies supported by an infrastructure of fume-hoods, kilo labs, analytical instrumentation and GMP as well as non-GMP production areas.

Services Offered include

  • Process Development
  • Analytical
  • Additional Services

Process Development Services

  • Process development for pre-clinical and clinical supplies
  • Process / route selection
  • Pre-clinical (non-GMP and GMP) manufacturing
  • Manufacturing support
  • Process engineering
  • Solvent CC reduction
  • Yield improvement
  • Capacity de-bottlenecking

Analytical Services

  • Analytical method validation and method transfer
  • Reference standard qualification
  • Testing of raw materials
  • Intermediates and finished product testing
  • Third party sample analyses
  • In-process checks, cleaning verification
  • Wet Chemistry and Compendial tests
  • Stability studies as per ICH guidelines
  • Stability chambers / freezers

Additional Services

  • Impurities and Reference Standards
  • Sample preparation for toxicity studies
  • Critical parameter assessment
  • Documentation

Locations

  • Torcan, Canada
  • Ennore, India
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