Formulation Development
Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic. Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer early-phase accelerated programs for NCEs and generic drug development for human and veterinary applications (ANDAs and ANADAs).
Core Capabilities:
Accelerated first-in-human clinical trial materials
Bioavailabilty enhancement
Clinical formulation development
Commercial dosage form design
Drug candidate selection
Drug excipient compatibility studies
Injectable prototype development
Matching placebo development
Drug product lifecycle management
Drug substance pre-formulation studies
Pediatric formulation development
Pharmaceutical process development
Powders for reconstitution
Preclinical formulation development
Quality by design (QbD)
Solid oral dose prototype development
Technology transfer and process
scale-up
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