Regulatory Affairs

A well trained team of competent and qualified persons are responsible to validate products and processes to demonstrate that they meet requirements of quality including safety, efficacy, purity and identity they claim to possess. Manufacturing facility along with the laboratory is adequately resourced with appropriate qualified staff, equipment and facility. Prescribed quality standards are supported through well-defined and documented quality assurance system and procedure.

Elysium provides services like ANDA Filings, Dossier Filing for regulated and Semi markets, stability studies, environment validation, machine validation, manpower validations, process validations , method validations and product validations.