Regulatory Affairs (RA)
We plan, prepare and file regulatory submissions for the Canadian market, and coordinate with other regions when needed. Zenith team handles strategy, submissions and life-cycle changes for drugs, biologics, devices and combination products.
EXPERTISE
We support
Innovators in rare disease, oncology and advanced therapies, as well as generics and established products. We also support device and combination products needing aligned PV, QA and RA deliverables.
OUR SOLUTIONS
Core RA Services
Discover our key offerings, customizable to your needs. While these highlight frequent services, we adapt for specialty medications or global queries.
- Regulatory pathway and evidence plan (Health Canada with FDA/EMA alignment where in scope)
- Meeting preparation and briefing packages for Health Canada (e.g., pre-CTA, scientific advice)
- Submission roadmap with roles, timelines and required documents
- Product monographs, labels and artworks; change control and proofs
- DIN life-cycle maintenance and co-ordination with supply/QA for release readiness
- Canadian bilingual materials and plain-language review
- Classification and Request for Designation support
- Device submissions (where applicable), plus combination product alignment across RA, QA and PV
- Canadian adaptation of global RMPs
- Educational materials and documentation of effectiveness checks
- Risk tracking and periodic review inputs
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- Version control, traceability, and submission archives suitable for inspection
- Secure document exchange and clear file ownership
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Book A Discovery Call
Book a discovery call with a Zenith PV senior partner today to discuss your needs, uncover gaps, and kickstart your compliance journey.
How we work
Our RA services seamlessly integrate with pharmacovigilance, ensuring submissions incorporate robust safety data from aggregate reports and audits. This holistic approach, rooted in our core values of trust and ownership, delivers compliant outcomes that enhance physician preference and brand loyalty.
Clear scope
What will be filed, when, and with which evidence
Defined outputs
Checklists, templates and a submission calendar you can share with internal teams.
Canadian Team
Versioned documents, response logs and eCTD build reports kept on file.
Bilingual Services
English and French as needed.
Typical starting points
Gap Review
A short gap review on a planned submission or CTA
DIN Amendment
A stalled variation or DIN amendment that requires structured responses
Labelling Update
A labelling update that needs evidence and clean proofs
English 
French