Specialists in Fermentation based APIs Contract service provider for R & D, assay development, stability studies, process scale-up and optimization as well as CGMP manufacturing up to commercial scale.   Quality Control and Methods Development     Quality Assurance     Regulatory Affairs
	Regulatory Affairs   Our facility has been set up to carry out fermentations of multiple scales and a wide variety of isolation techniques for recovery of secondary metabolites from fermentation broths, while ensuring a high degree of compliance in quality and operations meeting international regulatory requirements. We have regulatory submissions (Drug Master Files) in all major regulatory jurisdictions and have undergone regulatory agency inspection resulting in approvals being granted to our customers for use of materials manufactured at our site in their formulations.
	Quality Control and Methods Development     Quality Assurance     Regulatory Affairs     Legal and Copyright Terms