Mycenax Biotech Inc.

EN

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Project Management and Regulatory Support

Mycenax is a reliable partner to you and provides you with all required support and expertise for the successful execution of your project.  
 

Project Management

A project manager is assigned to your project as the main point of contact and will accompany you all the way from the beginning till the end of the project. Our project managers are well trained in the manufacturing technologies as well as regulatory aspects for biopharmaceutical development.
 

Regulatory Support

Mycenax has broad regulatory experience and in-depth knowledge of biological drug development for all major global markets. We support you to develop optimal approval strategies and to create approval documents that meet global regulatory requirements. We prepare the complete CMC documentation for applications of clinical trials (IMPD/ IND) or marketing authorization (MAA/ NDA/ BLA). We also advise you in answering regulatory questions and support you to prepare and conduct agency interactions.
 

Data Security

Your product information and data have the highest value for us. Therefore, Mycenax has implemented a company-wide security system to protect all product-related documents.