Regulatory Support
Quality + Safety + Transparency
We strive for excellence in all areas of our work, ensuring that every system and team delivers top-notch results. As a result, we are able to provide exceptional support for your product’s regulatory requirements.
Our Capabilities
We are committed to regulatory excellence. Navigate the complex world of regulatory pathways and requirements with confidence. Our extensive expertise ensures that we understand and support your unique regulatory challenges.
Partnering with Novex Innovations means you have a trustworthy team on your journey to regulatory excellence.
We can help with:
- Product Development Strategy
- Master File Development
- Investigational New Drug (IND) Applications
- Pre-Clinical Study Design
- Chemistry, Manufacturing and Controls (CMC) Development
- Biological License Applications (BLA)
- Medical Device 501(k)
- Preparation/Representation at Regulatory Meetings
- Regulatory Submissions, Amendments, Supplements & Reports
Looking for expert solutions in Regulatory Support?
We’re a reliable, experienced and adaptive partner focused on quality and adherence to regulations. Let’s talk about your next challenge together.
