The story of your medicinal product from its “birth” to the maturity test (= marketing authorisation). The end result: a comprehensive authorisation dossier. 💊
This determines whether your medicinal product is approved for the market. A huge responsibility – which we are happy to take on for you!
🤝 We combine the authorisation expertise of our Regulatory Affairs experts with the skills of our Medical Writers to put pharmaceutical, preclinical and clinical data on paper in a structured and comprehensible way.
Our services include the writing or evaluation of:
🔸 Module 1: Application Form, Product Information, Details of Experts, RMP, ERA
🔸 Module 2: Summaries
Module 2.3: Quality Overall Summary
Module 2.4: Non-clinical Overview
Module 2.5: Clinical Overview
Module 2.6: Non-clinical Summaries
Module 2.7: Clinical Summaries
🔸 Module 3: Quality
🔸 Module 4: Preclinical Data
🔸 Module 5: Clinical Data
Our expertise covers a wide range of approval types 👉 including generics, hybrid, well-established use, traditional herbal medicinal products (THMP), etc.
💡 Our many years of experience enable us to respond optimally to your individual needs and always find tailor-made solutions, even in complicated cases.
We look forward to writing the story of your medicinal product and bringing your products to the market together! 🚀