- An early integration of formulation and life cycle management for new chemical entities
- We conduct in-house development and current Good Manufacturing Practices (cGMP) manufacturing in FDA inspected facilities
- We have developed proprietary PLGA or polylactic-co-glycolic acid polymer-based delivery systems and nanoparticles
- Supply chains for clinical trials and commercial use in the United States, Europe and Japan
- We can manufacture from pilot batch to commercial scale
- We can do customised equipment engineering for specific processes
- We can provide a “Ready to use” supply chain and regulatory files
We work with active pharmaceutical ingredients (API) and formulated drug products for preclinical studies, clinical phases I to III and commercial scale. Our know-how covers API and drug product manufacturing, analytical method development and validation, quality control as well as packaging and supply chain.
At our cGMP production facility, inspected by the United States Food and Drug Administration (FDA) and Swissmedic, we can produce small batches of drug products for feasibility studies, through clinical trial supplies onto commercial scale manufacturing. We have extensive experience with both small molecule pharmaceuticals and biologics. Throughout the entire chain, we develop, conduct and control production processes to ensure that our products conform to specifications and respect international Good Laboratory Practice (cGLP) and cGMP guidelines.