Regulatory Support

SUPAC application support
GMP/FDA/ICH guidance
CMC report preparation for IND, NDA, ANDA submissions
Product development strategies

Formulation Evaluation
  • Content uniformity evaluation
  • Dissolution testing
  • Stability assessment
Regulatory Support
  • SUPAC application support
  • GMP/FDA/ICH guidance
  • Product development strategies
Analytical Services
  • HPLC based
  • Full ICH stability conditions
  • Dissolution testing
Clinical Manufacturing
  • cGMP manufacturing
  • Direct API fill into capsules
  • Dosage form preparation and blinding




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