Customer Synthesis & Contract Manufacturing of Active Pharmaceutical Ingredients (API)
Global Standards® has a broad expertise as manufacturer of API with a particular focus on potent substances and niche products. Our facilities allow the synthesis of smallest development batches and a scale up to batches up to kilogram quantities. API manufacturing is in compliance with GMP standards for clinical research and marketing batches.
Upon request, Global Standards® offers support to customers for achieving worldwide regulatory approvals of finished products containing Global Standards® API and for compiling the pharmaceutical dossiers accordingly (such as CEP, DMF, ASMF, IMPD/IND, IMA/MAA), and covering all the aspects of dossier life-cycle management.