Regulatory strategy plan for drug products and Medical Devices

Regulatory advising and services during clinical trial provide clinical strategy and regulatory approach service

Preparation and update of documentation for marketing authorization/renewal (CTD, NTA, NeeS) of drug products (modules 1, 2, 3, 4 and 5)

Translation of PIL and SPC according to current QRD format

Submission to the Regulatory Authorities and follow up of the process of all types of regulatory procedures