Regulatory Advising and Services

Regulatory strategy plan for drug products

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

Preparation of Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) to EU and the specific local requirements

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

Preparation and update of documentation for approval of food supplements