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Manufacturing

 

  • Early integration of formulation and life cycle management for new chemical entities
  • In-house development
  • Development of 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
  • Skills to do customized equipment engineering for specific processes
  • Ability to 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.

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.