Test Method Development

We have extensive experience in developing analytical test methods for various applications and across a variety of product types in compliance with international regulations. We can assist throughout the entire method development activity to meet your requirements. This includes project planning, protocol writing, execution, and final development reports to satisfy your regulatory needs.

Our analytical team has expertise in developing analytical methods in the following key areas:

  • Efficient and robust QC test methods
  • Stability indicating test methods in compliance with ICH guidelines
  • Methods for cleaning validation studies
  • Dissolution and drug-profiling methods
  • Compendial methods specific to your products

The dosage forms on which we work include:

  • Solid dose: tablets, hard gelatin capsules, granules, and powders.
  • Liquids: oral and topical liquids, suspensions and emulsions
  • Semi-solids: creams, ointments and gels