Our Small Molecules Platform provides full-service capabilities including Advanced Intermediates, Active Pharmaceutical Ingredient (API) Development & Manufacturing and Drug Products (Formulation & Packaging).
Process Development
Whether you have a medicinal chemistry route or a fully-developed Small Molecules process seeking initial implementation, our experienced team of development chemists and engineers are prepared to assist in successfully scaling up your process in a phase-appropriate manner, with a keen grasp of your future regulatory requirements.
Our Small Molecule API Development services include:
>> Route Selection
>> Process Development & Optimization (early to late-stage, small to large-scale)
>> Analytical Development & Validation Services
>> Synthesis & Purification of Analytical Reference Standards
>> ICH Stability Studies
Platform Capabilities
Small Molecule Drug Products
Solid Oral Drug Products (Tablets & Hard Capsules)
Terminally Sterilized Injectable Drug Products (Barrel Syringes, Vials & Ampoules)
Aseptic Filled Injectable Drug Products (Cartridges, Vials & PFs)
Packaging, Labeling & Serialisation
Small Molecule APIs
API Development (QbD)
Clinical Manufacturing of APIs & Advanced Intermediates