Formulation Development

Formulation Development

Different Formulation Development Services includes,

Literature search.

  • IP evaluation.
  • Pre-formulation studies.
  • Compatibility studies.
  • Formula finalization and optimization.

Analytical Development

  • Method development.
  • Container closure integrity method development.
  • Deactivation studies for Oncology drug products.
  • Exhibit batches related studies.

Analytical Method Validation

  • Method validation.
  • Container closure integrity method validation.
  • Cleaning method development and validation.

Technology Transfer

  • CMO identification for US market
  • CMO audit as per regulatory requirement
  • Support in execution of engineering and Exhibit batches

Dossier Submission

  • Admixture studies method development and validation
  • Reconstitution method development and validation
  • Temperature excursion studies
  • Extractables and Leachables study
  • Ink/glue migration studies