Regulatory Affairs officers ensure that products we import and distribute meet regulatory requirements set by the Regulatory Authority, WHO-GMP guideline, ICH guideline, Guidelines as set by Medicines and Healthcare products Regulatory Agency (MHRA), European Medicine Agency (EMA) and similar to Stringent Regulatory Authorities (SRA).
Regulatory team look after the registration of the companies and products with Government of Nepal, Department of Drug Administration. It gathers fact, evaluate, organize, manage and collate information and regulatory documents required to obtain Product and Marketing License and ensure its timely renewal.
Regulatory Affairs department keep up to date with changes in regulatory legislation and guidelines. Regulatory team collect and document the dossier from principal companies and ensure timely submission to Regulatory Authority. Regulatory team initiate the process of new product registration, old product renewal, re-registration and monitor the progress made at Regulatory Authority and follow up regarding the same. Regulatory team keep the principal companies apprised of all processes and progress of registration, re-registration and renewal.
For details about the requirements for registration and renewal procedure in Nepal please follow the link below: