• Quality Management System will be based on ICH & ISO 9000 guidelines within 18 months.
• Quality Management System will be comprehensive covering all cGMP aspects
• We will have a cGMP consultant and external Quality Auditor
• We will be having regular internal cGMP audit & continuous improvements
• We expect to be audited by European, Canadian & US customers
• Independent QA team will be in place once operations commence at new USFDA approvable commercial plant which is currently in project phase (all licenses in place, currently in design and planning stage, expected to be completed towards end of 2008).

Regulatory Support

Drug Master files (DMF’s)

The technical team at Mayuka Labs has rich industry experience in submitting DMF’s for chemical intermediates and active ingredients; Mayuka Labs strictly adheres to the regulations associated with the development of every new pharmaceutical ingredient and chemical entity.