Regulatory

Regulatory functions have come to the limelight within the last few years as issues of standardization, compliance and pharmacovigilance have come to play an increasing role in marketing and usage of pharmaceuticals worldwide. Stringent government regulations, drafted, implemented and monitored by the National Medicines Regulatory Authority (NMRA) of Sri Lanka, followed by web based dossier submission through CTD format and imposition of price controls poses new and daunting challenges to the Regulatory Department.

Our regulatory outfit consisting of trained pharmacists under the Head of Regulatory Affairs is well equipped to deal with all these challenges as they have years of experience in dealing with the health authorities coupled with the in-depth updated knowledge of international guidelines and quality assurance standards.