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, proof reading, and user testing: for compliance with labelling laws.
Registration of traditional herbal medicines
Product Rationale on scientific basis
Success and Us
Everything and Anything
Spark Pharma Regulatory is managed by a industry trained regulatory professional having invaluable Pharma experience from Reputed pharmaceutical company.
We assist our clients by guiding the product development in line with the country specific requirements, data generation, document compilation for submission to various Regulatory Agencies all over the world.
The registration being the pre-requisite for export to any market, the client gets all round assistance in technical data generation and regulatory strategy to enter new markets. Thus, enhancing their market portfolio and revenues.