Canary Regulatory Affairs
- Other products or services
- Other R&D services
Canary Regulatory Affairs provides expert regulatory strategy and guidance in CMC, preclinical and clinical development for pharmaceutical, biotech, and medical device companies. With a strong track record of successful scientific advice meetings with the US FDA (including Pre-IND, Type C, EOP2, and Pre-NDA), EMA, EU National Competent Authorities, and the Australian TGA, as well as NDA/MAA filings across multiple therapeutic areas, we help accelerate global approvals by supporting clients from early development through registration,
Our team delivers integrated support across quality, non-clinical, and clinical disciplines. We focus on practical, solutions-driven strategies that keep development on track and help bring therapies to patients.
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