Regulatory
We know where you want to be and how to get you there. Our intricate knowledge of global and local regulatory requirements helps us achieve swift approvals for your products across your target markets.
Why work with Enzene for regulatory services?
Our expert team of regulatory professionals brings a wealth of experience and knowledge to your project.
Expertise
Our regulatory team specializes in guiding developers through complex regulatory requirements.
Global reach
We have a deep understanding of global and local regulatory requirements with close relationships with regulatory bodies such as the DCG, EMA and USFDA enabling us to provide guidance specific to your target markets.
Swift approvals
Our efficient processes and strategic planning help accelerate the approval process, ensuring your products reach the market faster.
Comprehensive support
We offer comprehensive regulatory services, the preparation of dossiers supporting common technical document (CTD) filings from preclinical studies to marketing authorization application (MAA)
Commitment to quality
We are committed to delivering high-quality products to consistently meet regulatory standards.
Join the revolution
Fueled by our continuous innovation and armed with EnzeneX™, our fully-integrated CDMO solutions and our biosimilars pipeline are designed to help bring your biologics innovations to life.