Services
Regulatory Affairs
Regulatory strategy and submission support for FDA, Health Canada, and EU pathways.
MetaPharm Inc.’s experts accompany you through all stages of your product’s journey. Your clinical trial will benefit from our experience in developing regulatory strategies for the FDA, Health Canada and the EU, in addition to our expertise with NIH and DoD federal grants. Our experienced team provides regulatory support during pre-IND, IDE, de novo, and other formal meetings, as well as scientific advice with the FDA, and accompanies your complete submission process in the US and Canada.
- Pre-IND, IDE, and de novo meeting support
- FDA, Health Canada, and EU strategy
- CTA/IND submission support
- Scientific advice and agency interactions
Regulatory Affairs
How we deliver
- · Dedicated project ownership from kickoff to close-out
- · Quality systems aligned to ICH-GCP standards
- · Clear communication with Canada-based leadership
- · Technology-enabled, inspection-ready documentation
Next step
Ready to discuss your clinical development plan?
Contact MetaPharm Clinical Research INC. to explore strategic consulting, study execution, and full-service CRO partnership across Canada and global programs.