Services

We offer a broad range of process and analytical services. We are able to provide such services for all stages of product development. In addition,  we have a solid track record in upgrading and improving existing formulations and analytical methodologies.

Services offered:

i. Analytical Development
  • Analytical Method Development & Validation
  • Cleaning Residuals Validation
  • Dissolution and Drug Release Profile
  • Stability Monitoring


ii. Pre-formulation

  • Physical Properties
  • Powder Characterization
  • Forced Degradation Studies
  • Compatibility Studies


iii. Formulation Development

  • Prototype Formulation
  • Preliminary Process Development 

 
iv. Clinical Trial Manufacturing & Scale-up

  • Process Optimization
  • Scaling up
  • Clinical Trial Manufacturing
  • Commercial Product Manufacturing & Process Validation


v. Stability studies

  • ICH conditions
  • Studies & Reporting 


vi. Registration support

  • Validation Protocols & Reports
  • Documentation Support
  • CTD writing
  • Registration Strategy Development

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