Global Regulatory Submissions, Inc
Navigating Global Regulatory Submissions with Expertise and Precision.
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.
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.
Cosmetic Submission Services
US Cosmetic Submission Services that aligns formulas, labels, and submissions so brands enter and grow in the market confidently.
Over-the-Counter Drug Submission
OTC and NHP filing support for Canada and the USA, guiding category selection, monograph alignment, and dossier preparation.
Export Documentation Services
Export documentation, including Certificates of Free Sale and Country of Origin, delivered at about one quarter typical cost and time.
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.