Regulatory Support
We have a proven track record with regulatory bodies, consistently achieving compliance with regulatory guidelines worldwide and maintaining robust Quality Management Systems. Our dedicated regulatory affairs team guides you through submissions and creates a proactive risk management plan to help you navigate complex regulatory landscapes with confidence.
Our team is dedicated to navigating complex processes, ensuring compliance, and delivering results that exceed expectations, all while maintaining open communication and a commitment to your goals. We’ve supported dozens of product approvals and NPIs (new product introductions) worldwide, including sterile complex formulations. Our regulatory experience includes the following:
- US FDA
- Health Canada
- PMDA Japan
- EMA EU
- MFDS South Korea
- ANVISA Brazil
- TGA Australia
- MOH Russia
- MOH Türkiye
- And more
Ready to get started?
JHS delivers white-glove service and world-class sterile injectable manufacturing—tailored to your product, your timeline, and your goals.
Connect with our team today and discover how we can bring your drug product to your patients quickly.