Exclusives

We provide the following exclusive products and services.

Multi-Scale cGMP Manufacturing

• Kilo to ton quantities, including synthesis of 100s of gram quantities for pre-IND screening, cGMP production for phase I to phase III clinical studies, NDA validation batches and cGMP production for commercial quantities after NDA approval
• Multi-scale manufacturing from oral to parenteral use, including sterile bulk
• Multi-scale manufacturing of regulated intermediates as well as APIs
• Particle Design
• cGMP spray drying at all scales
• Controlled particle size reduction using state-of-the-art technologies
• Micronization of APIs for oral, topical, injectable and inhalation use

Process Development R&D

• Route discovery
• Process development
• Proven acceptable range (PAR) studies
• Process engineering and industrialization