From initial API characterization and early solid dose evaluation, Asymchem covers all the bases. We use QbD and DOE to develop and optimize formulations and solid dosage forms for robust manufacturing, with an eye towards eventual NDA filing and process validation. Thorough product knowledge and understanding is the goal.
Asymchem produces smaller early-phase clinical supplies, and can scale up to larger later-phase trials, and eventual commercial-scale production. Asymchem offers full validation support, and has much experience with technology transfers, if client decides to transfer commercial production elsewhere.