We can assist with project management and registration of such products and have valuable experience in this area. We can work with you to guide you through the necessary requirements under the Directive that you will have to comply with. We can either prepare for you or help you to prepare a submission for a traditional herbal medicinal product, including vital pre-submission discussions with the Health Authorities.
Our services include the following:
Preparation and review of Traditional Herbal Registration Dossiers
Preparation of Patient information leaflet (PIL), writing, proofreading, and user testing: for compliance with labeling laws.
Registration of traditional herbal medicines
Product Rationale on the scientific basis