Step 8:

Regulatory & Security

Compliance Without the Complexity

With evolving regulations and rising data protection requirements, ObvioGo helps study teams stay a step ahead. By embedding global compliance standards into every trial, the platform reduces risk, simplifies documentation, and supports confident regulatory submissions at every phase.

A Trusted Partner in Global Compliance

With a 20-year legacy in clinical research through our parent company, SPRIM, ObvioHealth brings deep regulatory expertise across global markets. Designed to meet the evolving requirements of the FDA, EMA, FSANZ, and other national authorities, the ObvioGo platform enables faster, more compliant study execution—reducing delays and strengthening submission readiness.

Regulatory Intelligence & Submissions

RegASK, our sister venture, specializes in global regulatory intelligence and submission strategy. In close collaboration with ObvioHealth, their experts optimize study design for claims substantiation, provide region-specific guidance, and act as your representative for smooth, compliant submissions across the U.S., EU, Asia-Pacific, LATAM, and beyond.

Regulatory Efficiency

Accelerate study setup with early-stage regulatory input—avoiding delays from protocol amendments and reducing submission rework.

Localized Compliance

Leverage region-specific regulatory intelligence to ensure study designs meet local agency expectations across the U.S., EU, APAC, and LATAM.

Faster Market Readiness

Streamline end-to-end submission workflows and documentation to reach key markets faster—with fewer barriers to approval.

Enterprise-Grade Security Standards

ObvioGo is designed with clinical-grade security at its core—ensuring that every trial is audit-ready and globally compliant. The platform adheres to 21 CFR Part 11, ICH-GCP, and GDPR, and holds ISO 27001, 27017, and 27701 certifications. All activity is logged, time-stamped, and access-controlled to support full data traceability and integrity from start to finish.

Regulatory Confidence

Navigate global submissions with fewer delays and more assurance.

Data Protection by Design

Privacy safeguards are embedded from the ground up, aligned with global laws.

Transparent Operations

Role-based audit trails and compliance documentation—automated.

Compliance You Can Trust

With our unified approach to regulatory alignment and security, you gain a partner equipped to support inspection readiness, de-risk global submissions, and protect sensitive data—every step of the way.

Making Real Impact