Regulatory affairs
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 are regulatory affairs important?
Our regulatory affairs team is responsible for guiding biologics developers through domestic and international regulatory requirements.
This includes supporting the development of documentation from the preclinical stages to commercialization, SOP streamlining, step-by-step review of data for compliance and regular internal audits.
Understanding our regulatory affairs capabilities
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
Why partner with Enzene?
We are a global Continuously Innovative Development and Manufacturing Organization (CIDMO), dedicated to changing the paradigm by which affordable biologic and biosimilar medicines are brought to market. Since Enzene’s inception, our innovative agility has enabled us to continually introduce transformative processes in biologics manufacturing that significantly increase product yields of complex biologics and monoclonal antibodies (mAbs) while reducing the manufacturing footprint and the cost of production.
Game-changing innovation is only the beginning, though. We are Enzene, and that means that our values of innovation, entrepreneurship, respect, candor, excellence, and integrity underscore everything we do from project management and communications to teamwork and ideation. To us, true partnership is about driving biotech innovation while doing so in a way that develops long-lasting trusted partnerships.
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Join the CDMO 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.