Regulatory Consulting
Expert Guidance from Your Specialized Regulatory Affairs Consultant for IVD and Point-of-Care Diagnostics
Experience Working With Regulatory Bodies
Navigating the complex regulatory landscape of diagnostics requires deep expertise, precise documentation, and proactive planning. As your trusted regulatory affairs consultant, Gila Bioscience offers strategic and technical consulting services tailored for in vitro diagnostic (IVD) product development, with a focus on rapid, point-of-care testing.
Our team has decades of experience working with FDA, USDA, and international regulatory bodies, giving you the guidance needed to move confidently through submission, review, and approval.
Our Regulatory Affairs Services
From the start, we help define the most efficient regulatory path for your assay based on its intended use, market, and platform reducing risk and avoiding costly delays.
We assist with all major submission types, including:
- FDA Pre-submissions (Q-sub)
- USDA licensing packages
- IVDR technical files
- Design History Files & Risk
- Management Plans
We audit your current documentation and data to identify any regulatory or quality gaps prior to submission or scale-up.
We ensure your product development process aligns with 21 CFR Part 820 and ISO 13485 design control requirements including DHF, DMR, and DHR documentation.
Need to manage a recall, respond to an audit, or handle a labeling change? We provide post-approval regulatory support to ensure ongoing compliance.
Our Regulatory Consulting Services Are Trusted By
IVD start-ups launching their first product
Established diagnostic companies expanding into new regions
Government contractors developing field-based assays for biodefense or environmental monitoring
Veterinary and food safety assay developers navigating USDA or AOAC approvals
What Sets Us Apart
Diagnostic-Specific Expertise
We don’t generalize, we specialize in regulatory support for rapid diagnostic assays.
Integrated With Development
As both your CDMO and regulatory affairs consultant, we ensure your assay is designed from day one with approval in mind.
Regulatory Documentation Ownership
All submission-ready documents are transparently developed and owned by you.
Track Record of Success
Our consultants have supported dozens of products through FDA clearance, USDA licensing, and IVDR.
Let’s Streamline Your Regulatory Journey
Whether you’re at the early feasibility stage or finalizing a regulatory submission, Gila Bioscience is your strategic partner in diagnostics.
(833) 710-0912
info@gilabioscience.com