About

Pattern of USA Inc., together with its advanced SaaS platform RAPAhub, forms a comprehensive ecosystem for regulatory intelligence, compliance, and market access solutions tailored for the life sciences industry.

Headquartered in Miami, Florida, Pattern of USA Inc. brings over 20 years of experience in global Regulatory Affairs consulting, offering expertise across pharmaceuticals, biologics, medical devices, in vitro diagnostics (IVD), veterinary products, food supplements, cosmetics, and consumer health goods. RAPAhub complements this by offering a next-generation digital interface—enabling clients to manage regulatory data, submissions, and compliance workflows in real time.

Our combined services cover the full lifecycle of product development and market entry:

Regulatory Strategy & Roadmaps (including US FDA, EMA, Health Canada, LATAM, MENA, and APAC regions)
Risk Evaluation and Mitigation Strategies (REMS)
Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) consulting
510(k), PMA, NDA, ANDA, IND, and BLA submissions
Clinical Trial Applications and IRB Support
Pharmacovigilance (including PSURs, LQPPV/DLQPPV)
Labeling and Product Classification
Market Access, Pricing & Reimbursement
Local Representation and License Holding (US Agent, EU RP, UK RP)
RAPAhub, our cloud-based SaaS platform, simplifies Regulatory Affairs project management by offering:

AI-powered document control and regulatory database integration
Collaborative compliance tracking across global markets
Custom dashboards aligned with ISO 9001, ISO 27001, GDPR, and FDA 21 CFR Part 11
Templates, workflow automation, and audit-ready records
Integrated GDP Matrix for strategic market selection based on PPP, GDP, and population analytics
We serve startups, midsize innovators, and multinational corporations seeking faster approvals, reduced compliance costs, and reliable market access across regulated regions.

Why choose Pattern of USA + RAPAhub?

Proven record with FDA and international agencies
Deep understanding of regulatory science and technology
One-stop global compliance hub powered by intelligent automation
Transparent pricing, fast turnaround, and unmatched customer service
Whether you're launching a new product, relocating manufacturing to the U.S., or preparing for a regulatory audit, Pattern of USA Inc. and RAPAhub are your trusted partners in regulatory success.

Discover more at www.patternofusa.com and www.rapahub.com
Inquiries: info@patternofusa.com