Preclinical Product Development Services

Targeted development services that expeditiously facilitate preclinical animal PK/tox studies and first-in-human (FIH) trials using limited API quantities and fit-for-purpose formulations comprising:

Drug Candidate Characterization

  • Physicochemical

  • Morphological

  • Biopharmaceutical

Drug Candidate Performance Improvement

  • Enhance aqueous solubility and improve chemical stability, if needed

  • Develop appropriate analytical methods to support activities

Animal PK/tox Formulations Development

  • Dosage forms

    • Tablets​​

    • Pellets in capsules

    • Powder in capsules

    • Solution

    • Suspension

    • Microparticles

  • Develop analytical methods

FIH Formulation Development

  • Dosage forms

    • Tablets​​

    • Pellets in capsules

    • Granules in capsules

    • Powder in capsules

    • Liquid/Semisolid in capsules

    • Microparticles (dispersible)

  • Develop analytical methods