Built On A Decade In Regulations
Global Regulatory Submissions, Inc grew out of more than ten years working directly on Health Canada and FDA files. Starting as a subcontractor, then advancing as a regulatory specialist, our founder saw how slow, fragmented support stalled launches. In 2020 we formalized those insights into a focused firm that handles real submission work, not theory, so clients gain regulator ready documents, predictable timelines, and clear pathways for drugs, cosmetics, OTCs, NHPs, and exports.
Precision, Speed, and Measurable Value
Our philosophy is simple, every submission must be accurate, efficient, and commercially meaningful. We design processes that cut rework, anticipate regulator questions, and shorten review cycles, while our export documentation model consistently delivers Certificates of Free Sale and Country of Origin documents at roughly one quarter of usual industry cost and time. Clients see the impact in fewer holds, cleaner correspondence with authorities, and faster, lower risk entry into Canadian and US markets.
Remote First, Always Accessible
We work primarily through structured remote consultations, secure document sharing, and formal written communication, which keeps projects moving regardless of location. Clients interface directly with senior regulatory professionals who understand MoCRA, GHS aligned SDS requirements, and cross border filings. Questions receive clear, practical answers rather than jargon heavy memos. This model lets internal teams stay focused on development while we manage the regulatory detail. When needed, we support face to face meetings for critical milestones.
Accuracy
Every dossier, notification, SDS, and export form is built to current Health Canada, FDA, MoCRA, and GHS expectations.
Canada & U.S. Expertise
Specialized knowledge of submission requirements across Canadian and U.S. regulatory frameworks, ensuring accurate and compliant documentation.
Partnership
We act as a practical extension of your team, aligning our work with your timelines and risk tolerance, goals, and regulatory requirements.