Herbal Drugs 2017-05-16T17:10:16+00:00

Herbal Drugs

a&r supports its clients with the registration of traditional herbal medicinal products (THMP), with the authorization of drugs based on well-established use (WEU), or with the new development of new products. a&r has amassed experience in the areas of pharmacology, biology, and medicine, and has been involved during the last 20 years in more than 300 authorization/registration procedures for herbal drugs, mainly in Europe, but also in the USA and Asia.

Regulatory Affairs

Apart from comprehensive assistance with the full marketing authorization or, respectively, registration of herbal medicinal products or single substances, we also offer individual services.

a&r’s services include:

•    Gap analyses of existing registration documentation
•    Development of the optimum regulatory strategy
•    Drawing up and/or updating of the Common Technical Document (CTD)
•    Expert statements
•    Proof of tradition for Traditional Herbal Medicinal Products (THMP)
•    Preparation of and assistance with meetings with drug authorities

Pharmacovigilance

a&r offers comprehensive consultation in matters of regulatory requirements for drug safety where it concerns the life cycle of your products.

a&r’s services include:

•    Drawing up of PSURs (Perodic Safety Update Reports) for herbal medicinal products
•    Literature research and intepretation of scientific data for the drawing up of required dossiers or statements
•    Compilation of risk management plans (RMPs)