We guide the entire PMA submission process from start to finish, ensuring that your medical devices meet FDA requirements, and the submission is safe, effective, and compliant, facilitating a smoother approval process for your product.
ADBC CRO specializes in the process of helping medical device manufacturers submit PMA applications to the FDA. PMA is required for a high-risk device, but the process involves the creation of detailed documentation and clinical evidence to show the safety and effectiveness of the device. Our team focuses on the streamlining of this process by providing you with solutions tailored to the requirements of the FDA and helping speed up the process for your device’s market.
Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.