Much of our work is based around the life cycle of a New Chemical Entity (NCE), however we have in-house expertise in all key related sectors. We provide an overview and background information about each sector for those new to regulatory affairs or who want to find out more. We also highlight any difficulties that may hold up a regulatory approval. Our expertise covers the following areas:
- Generics and Known Drug Substances
- Medical Devices and In-Vitro Diagnostics
- Borderline Products
Real Regulatory takes pride in the breadth of our capabilities and our success in working with clients whose needs may be broad ranging. Our extensive panel of external experts provide country, language and legislative expertise to complement our internal resources.