From Molecule to Medicine
Do you have a promising compound ready for development?
Do your shareholders want to see a sound plan to bring it to the market?
Zwiers Regulatory Consultancy takes a special interest in helping start ups to increase chances of success.
We will discuss regulatory possibilities and challenges with you and present the results in a regulatory strategy plan. As discussions with the health authorities will also play an important part in the strategy, we will advise on when and how to approach health authorities.
Your drug in development may be very promising. You may be using a highly innovative technology. You may intend to serve a specific population. Or to treat a neglected or rare disease. Or maybe your product is in another way distinctively different from regular therapies. Because of its unique profile, the regular regulatory guidance may not apply or there may be a smart marketing authorization route. We will explore alternative pathways for you.
- accelerated review
- orphan drug status designation
- WHO prequalification
- Article 58 procedure
- paediatric-use marketing authorizations
- biosimilar regulatory pathways
- compassionate use
- specific pathways for medical devices and combination products
Not only do we provide you with strategic advice, we actually execute the plan. We prepare all documentation, e.g. clinical trial applications, target product profiles, requests for specific procedures, meeting packages and, ultimately, the application dossiers.