Global Regulatory Submissions, Inc
Navigating Global Regulatory Submissions with Expertise and Precision.
How We Work
We start with a focused remote consultation to clarify product scope, markets, and timelines. Next, we assess regulatory pathways for Canada and the USA, confirm data gaps, and outline a clear workplan. We then prepare submissions, SDSs, or export documents, coordinate testing where needed, and manage revisions. Each deliverable is reviewed against Health Canada and FDA expectations before submission, ensuring you receive regulator ready documentation and predictable turnaround for every project.
Regulatory And Export Services
Secure compliant access to Canada and the USA while controlling cost and timelines. We manage Drug and Cosmetic Submissions, MoCRA and NHP filings, OTC registrations, GHS compliant SDS preparation, and export documentation, including Certificates of Free Sale and Country of Origin documentation. Our processes cut export document cost and turnaround to roughly one quarter of typical providers, so your teams stay focused on development and sales while we handle regulator ready documentation and communication.
Services Offered
Cosmetics Submission Services
Cosmetics are regulated to ensure they are safe, properly labelled, and free of prohibited ingredients.
Why Clients Trust Our Team
Global Regulatory Submissions, Inc grew out of more than a decade spent inside Health Canada and FDA facing projects, first as a subcontractor and then as a Regulatory Specialist. Formal operations began in 2024, yet our roots in regulatory work extend back to 2020. We focus on practical results, not theory, which means submissions, SDSs, and export documents that regulators accept and distributors respect. Our clients value cost control, predictable timelines, and direct access to senior regulatory guidance.
Export Speed Advantage
Secure Certificates of Free Sale and COO quickly, at about one quarter standard cost and turnaround, with reliable expert support.
Regulatory Depth
Rely on integrated Health Canada and FDA knowledge, including MoCRA and GHS compliant SDS requirements, for accurate regulatory submissions.
Remote Client Support
Work with a senior regulatory partner through structured online consultations, clear deliverables, and transparent communication throughout.
About Us
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.