Herbal Medicines and Medical Devices
At Pharmanager Development, we leverage our expertise to support our clients in the field of pharmaceutical specialties. Whether it concerns herbal medicines or medical devices, we help you navigate regulatory complexities while ensuring an effective strategy for bringing your products to market. Thanks to our know-how, we provide tailored solutions to maximize your chances of success.
Herbal Medicines
Herbal medicines require specific expertise for their development and market authorization.
At Pharmanager Development, we assist you in defining your regulatory strategy, preparing high-quality dossiers, and completing the necessary steps to obtain market authorization. Our experts guide you at every stage to ensure compliance and the success of your projects.
Medical Devices
Medical devices involve strict regulatory requirements and a structured process to obtain certification.
We provide personalized support, including regulatory classification assessment, feasibility analysis, and clinical evaluation. From technical documentation to CE certification procedures, we offer our expertise to ensure compliance and the safety of your medical devices.
Our answers to your questions
What are the steps for obtaining market authorization (MA) for an herbal medicine?
To obtain an MA, a comprehensive dossier must be prepared, including plant monographs, safety and efficacy studies, and product quality data. Our experts guide you through all these steps to ensure compliance.
How is a medical device classified under European regulations?
The classification of a medical device depends on its intended use and associated risks. We assess your product according to Regulation 2017/745, determining its regulatory class and guiding your compliance strategy.
What are the timelines for obtaining CE certification?
Timelines vary depending on the device class and dossier complexity. Our team optimizes each step of the process to reduce delays and ensure a fast and compliant submission.
Do you offer a dossier review service before submission?
Yes, we provide a detailed analysis of your dossiers to identify any non-compliance issues and ensure their acceptance by the competent authorities.