Our Services

Regulatory Affairs

At VJO Canada, our regulatory affairs services extend far beyond submission logistics—we serve as your strategic partner in navigating the complexities of global regulatory landscapes.


From clinical trial authorization to post-marketing lifecycle management, we deliver hands-on expertise, proactive guidance, and direct agency engagement to keep your program aligned, compliant, and moving forward.



Our Regulatory Services Include:


  • Quality Oversight & Vendor Audits

- On-site vendor qualification

- Execution of quality assurance and regulatory compliance audits

- SOP evaluation to ensure regulatory alignment


  • Regulatory Authority Engagement

- Direct interactions with Health Canada, FDA, and other global agencies on your behalf

- Preparation and support for regulatory consultation meetings, pre-IND/CTA, EOP1, EOP2, and pre-NDA discussions

- Act as U.S. Agent and Canadian regulatory representative for foreign sponsors


  • Application Support

- Preparation and submission of both paper and electronic applications (eCTD)

- Support for:

  • Clinical Trial Applications (CTAs, INDs)
  • Marketing Applications (NDA, BLA, NDS, MAA)
  • Post-Approval Changes & Lifecycle Management


  • Strategic Regulatory Planning

- Development of regulatory strategy aligned with target market and product profile

- Issue resolution and negotiation support during review cycles

- Identification of opportunities for expedited approval (e.g., Fast Track, Breakthrough Therapy, Priority Review)



Why VJO Canada for Regulatory Affairs?


We bring together scientific, operational, and regulatory expertise to deliver a full-spectrum approach to compliance. Whether you’re preparing for your first IND or managing lifecycle changes post-approval, our tailored strategies and hands-on execution help reduce risk, gain clarity, and accelerate time to market.