At BlueThread Regulatory, we specialize in navigating the complex global regulatory landscape for drug/device combination products. With over a decade of hands-on experience, we provide expert guidance to help life sciences companies bring innovative therapies to market and maintain compliance throughout the product lifecycle.

Our Expertise

We offer strategic and operational consulting in:

• Global Regulatory Strategy for combination products

• Quality System Implementation tailored to combination product requirements

• Pre-Market Planning including regulatory submissions and pathway analysis

• Post-Market Compliance and lifecycle maintenance

• Risk Management and regulatory intelligence

Our deep understanding of the intersection between pharmaceutical and medical device regulations ensures that your combination products meet the highest standards of safety, efficacy, and compliance.

Industry Leadership

Our founder is a voting member of the ISO 12417: Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products working group, contributing to the development of international standards for vascular device-drug combination products. This role reflects our commitment to shaping the future of combination product regulation and staying at the forefront of industry developments.

Why Choose Us?

• 10+ Years of Experience in regulatory affairs and quality systems

• Global Perspective with insights into U.S., EU, and international regulatory frameworks

• Tailored Solutions that align with your product’s unique needs and business goals

• Strong Network built from years of working closely with engineering, quality assurance, market surveillance, and risk management teams

• Trusted Partner for startups, established manufacturers, and everything in between

Whether you're preparing for market entry or navigating post-market challenges, we’re here to support your success every step of the way.