Clinical
Formulation

We support customers in developing compliant drug products for clinical-stage requirements, with focus on target quality attributes and performance objectives. Extensive experience in NCE formulation development, combined with flexible strategies to meet customer needs, enable us to efficiently and rapidly resolve key challenges of dissolution, flowability, wettability, stability and bioavailability. With strong analytical skills in method development and validation, and a quality by design (QbD) approach, we facilitate speedy IND/NDA filing.

Our technology transfer team has successfully translated formulation technologies developed in our laboratories to manufacturing scale, to ensure timely supply of drug products for clinical trials.

Preformulation Studies

• Drug substance characterization
• Drug excipient compatibility studies
• Container closure compatibility studies
• Stress stability studies
• Dosage form enabling studies
• Analytical method development

Formulation Development

• Tablets (immediate and modified release)
• Capsules (powder and pellet)
• Liquid orals
• Novel drug delivery systems
• Injectable and ophthalmic formulations
• Complex injectable formulations
• Semisolid formulations
• Analytical method development and validation
• Stability studies