Product Development
Parsolex Product Development Solutions can meet the development needs of clients from pre-Phase I through small Phase III production as well as legacy drug commercialization. We have combined deep scientific experts with innovative laboratory capabilities to address a broad range of development challenges for solid oral dosage forms, including but not limited to tablets, film-coated tablets, and hard gelatin capsules filled with powder, granule, and coated-beads. Our efforts have resulted in a demonstrated track record of tackling a myriad of technical challenges in drug product formulation design, process development, technology transfer, and scale-up of processes, all while complying fully with CGMP regulations enforced by the Food and Drug Administration (“FDA”).
- Pre-Formulation
- Clinical-Enabling Formulation Development
- Commercial Formulation Design
- Process Development & Scale-up
- Quality by Design (QbD)
- Process Analytical Technology (PAT)
Let us know how we can help with your Product Development challenges today.