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)
• Pharmacological, toxicological and clinical expert statements
• Proof of tradition for Traditional Herbal Medicinal Products (THMP)
• Preparation of and assistance with meetings with drug authorities