Regulatory Affairs - phyreg®
The right strategy is a decisive factor for success. Whether you seek a German or EU-wide marketing authorization, an approval based on a well-established use, a traditional herbal medicinal product registration or a marketing authorization based on own studies, PhytoLab will help you plan the right strategy for a successful authorization procedure and targeted implementation. We support you by preparing, participating in and following up on Scientific Advice procedures with the regulatory authorities involved and guide you through national procedures as well as Mutual Recognition Procedures (MRP) or Decentralised Procedures (DCP).
Our phyreg® Team can also provide you with expert advice concerning other product categories, including health claims for food supplements and functional foods, notification of a traditional novel food, foodstuffs for special consumer groups or substance-based medical devices.
For your medicinal products, we prepare tailor-made dossiers in CTD format. In doing so, we incorporate all our knowledge from more than 25 years of experience in the registration of herbal medicinal products. Tailored to your needs, we create complete dossiers or individual modules for further processing in your company. For your existing products we take over reformatting work, e.g. for baseline submissions in the context of eCTD submissions. Of course, all documents meet the technical eCTD requirements.
Our range of services also includes the creation of technically valid eCTD submission packages in accordance with the applicable specifications and submission via official gateways and portals.
Traditional herbal medicinal products
Directive 2004/24/EC for Traditional Herbal Medicinal Products offers the opportunity to develop new marketing strategies based on existing or formerly existing products. Under certain conditions, it is also possible to register innovative pharmaceutical forms or modernize dosages in order to better meet patient needs. We check the feasibility of products, develop creative product ideas for the expansion of your portfolio and document the traditional use as well as the plausibility of the efficacy and the safety of the product on the basis of extensive literature research.
At the beginning of a marketing authorization process there is an idea. In order to make this idea a success, we develop a transparent time and cost planning for you and, if desired, coordinate the processes from product development to the completion of the procedure.
We advise you on the selection of suitable active ingredients, arrange contact with suitable contract manufacturers, coordinate the development of analytical methods as well as the production and storage of stability batches and ensure that your projects run smoothly through effective networking among all participating partners. You can thus be certain that all approval documents are prepared on time, regulatory deadlines are met and you always have an overview of the schedule and cost development.
We also offer you our service for your food projects such as food supplements with innovative herbal ingredients.
After a successful approval of a medicinal product, there is still a lot to do: we offer you extensive support in the maintenance of your marketing authorizations and registrations, e.g. in the processing of post-approval conditions, renewals and national variations according to § 29 AMG or variations according to EU legislation. Here too, you can rely completely on timely processing and submission.
PhytoLab can support you in maintaining your marketing authorizations and take the burden off you by reliably tracking submission deadlines. We will proactively notify you of legal developments and assist you in planning the necessary steps to ensure the sustained marketability of your products.
Food / Health Claims
We can also advise you when it comes to the labelling and presentation of herbal foods and food supplements. Among other things, we support you in all questions regarding the Regulation (EC) No. 1924/2006 on nutrition and health claims and advise you on the usability of plant-derived ingredients in Germany and in the EU.
We will also be pleased to advise you on novel food issues, and here in particular on traditional foods from third countries.