Herbal product registration EU
Quality strategy and dossiers
Quality aspects of herbal (medicinal) products are key to registration and independent of its registration route. Strategic decisions during development and manufacturing have to be taken that impact the manufacturing method and quality control of herbal substances, intermediates and finished products. Product-related information on manufacturing procedures, control of critical steps, validation of manufacturing and analytical methods, and product stability needs to be provided. A high-quality dossier is a prerequisite for successful registration and within Kinesis an experienced team of consultants guides you through the strategic decisions and regulatory requirements.
Overviews/safety expert reports
Overviews of the available safety and efficacy data for herbal medicinal products are essential parts of the documentation necessary for registration. For traditionally used herbals, a significant amount of non-clinical and clinical information is often publically available. This information should be presented in an integrated format. The experienced team of consultants within Kinesis tailors the documents according to the regulatory requirements, with emphasis on the unique attributes of herbal products.
Regulatory dossiers and communication with authorities
Kinesis offers to manage and submit documentation in the required format (eCTD). Communication with the authorities and management of applications and post-approval activities are important parts of Kinesis’ core business. An experienced team of consultants, who previously worked for European regulatory authorities, offers a complete package of services to ensure rapid and effective submission of the registration dossier.
Meeting with the authorities provides a very useful opportunity to present the product and discuss different development and/or registration scenario’s. Kinesis organizes and prepares these meetings, supporting you in finding the most optimal regulatory strategy.