Comprehensive Support for Combination Products Compliance and Market Success

At MEDEVICE FDA Consulting, we understand the unique challenges of developing and bringing combination products to market. Our specialized expertise ensures that your drug-device, biologic-device, and other combination products meet the highest regulatory standards while maintaining patient safety and product effectiveness.

What Are Combination Products?

Combination products integrate medical devices, drugs, and biologics into a single product designed to deliver enhanced therapeutic benefits. These innovative solutions require a comprehensive understanding of the regulatory requirements for each component and the product as a whole. MEDEVICE provides the strategic guidance needed to navigate this complex landscape.

Regulatory Expertise and Strategic Guidance

Our team of regulatory experts brings in-depth knowledge of FDA and global requirements for combination products. We support your project from concept through commercialization, helping you address regulatory challenges and streamline the approval process.

• FDA Combination Product Submissions (IND, NDA, BLA, 510(k), PMA)
• Primary Mode of Action (PMOA) Determination
• Quality Management System (QMS) Alignment
• Clinical Development and Technical Documentation
• Risk Management and Post-Market Compliance

Customized Solutions for Your Product Needs

We recognize that every combination product is unique. Our tailored consulting services ensure that your specific product requirements are met with precision and efficiency. Whether you’re developing pre-filled syringes, drug-coated devices, or innovative delivery systems, MEDEVICE is your trusted partner.

Accelerate Time-to-Market with MEDEVICE

Time is critical in the development of life-changing medical innovations. MEDEVICE’s strategic approach minimizes delays by identifying regulatory pathways early and providing clear, actionable plans. Our proactive approach helps you avoid common pitfalls and maintain compliance without sacrificing speed.

Partner with MEDEVICE for Combination Product Success

With over 20 years of experience in medical device and combination product consulting, MEDEVICE offers the expertise and commitment you need to achieve market success. Our client-focused approach and global reach make us the preferred partner for companies aiming to innovate and improve patient outcomes.

Ready to bring your combination product to market with confidence? Contact MEDEVICE FDA Consulting today to get started.