Qualified freelance biologist with long experience in producing and editing technical texts in English and German for the authorisation of herbal medicinal products and the completion of clinical studies.

Services:

Producing, editing and proofreading scientific documents in English and German, with a focus on:

• Manuscripts for publication in scientific journals
• Literature research and assessment of bibliographical data
• Scientific statements on specific questions
• Documents to support applications for authorisation and registration of herbal medicinal products (CTD modules on efficacy, plausibility and safety of herbal medicinal products)
• Responses to deficiency letters on the medical, pharmacological and toxicological aspects in the authorisation procedure of herbal medicinal products
• Packaging texts (patient information leaflets and summaries of product information)
• Documents on pharmacovigilance according to the GVP (Good Pharmacovigilance Practices) regulations (PSUR, RMP, Addendum to the Clinical Overview)
• Documents for the completion of clinical studies according to the ICH-guideline for good clinical practice (GCP, e.g. study protocols, patient information, investigator information, final reports)
• Entries in public study registries
• Documents for the completion of observational studies and examinations of foodstuffs and cosmetics

Services in Cooperation

Technical translation of medical and pharmaceutical texts in cooperation with a qualified translator/interpreter for the language combinations English-German, German-English, Portuguese-German, Portuguese-English

I will be happy to discuss your specific inquiry with you in a non-binding conversation. I look forward to hearing from you.