Combination Product Services

We specialize in managing the process of streamlining the integrating of your selected device and drug product to accelerate the development of your combination product and speed to market.

Our comprehensive services cover a wide range of critical areas including:

  • Analytical services and design verification
  • Human factors and user experience management
  • Regulatory strategy and submission authoring
  • Drug/device assembly and packaging support.
Our expertise ensures you can confidently navigate the complexities of combination product developed knowing you have a trusted partner by your side to accelerate the process.

Analytical Services and Design Verification – Customized laboratory and testing services for your device

Our team of experts provides comprehensive analytical services and design verification to ensure the safety, efficacy, and compliance of your combination product. Leveraging advanced testing methodologies and equipment, we work closely with your formulation and active ingredients to verify the performance and integrity of your device and drug product while adhering to global standards. By conducting thorough analyses including mechanical and electronic performance testing, we mitigate risks and ensure regulatory compliance throughout the entire development process.

Human Factors and User Experience Management – Safe and effective devices surrounded by assets to drive engagement

We are trusted advisors in supporting the success of combination products across various regulatory pathways, device formats, and patient populations. Through usability studies and the application of human factors engineering principles, we enhance the usability, safety, and overall user satisfaction of your combination product. Our approach aligns with FDA Human Factors Engineering guidance and ISO 62366 requirements, ensuring the highest level of usability and user experience. This extends to providing comprehensive support in areas that ‘surround the device’ such as instructions for use, packaging, and training programs/devices to ensure optimal user engagement.

Regulatory Strategy and Submission Authoring – Accelerating your path to approval

Navigating the complex regulatory landscape is essential for obtaining market approval of your combination product. Our experienced regulatory team assists you in developing a comprehensive regulatory strategy tailored to your specific product and target markets. We guide you through the intricacies of regulatory requirements, including FDA regulations, international standards such as ISO 14971 and ISO 10993, and regional guidelines. With our experience in over 54 markets, we also provide support in authoring and compiling regulatory submissions, including premarket approval (PMA), 510(k), CE marking, and other necessary documentation, streamlining the submission process for you.

Drug/Device Assembly and Packaging Support – Managing the combination product

We can provide support for the whole of the combination product. We offer consultancy and partnership references for your drug container and compatibility. Our manufacturing sites can provide final assembly of the device and primary drug container including cold chain storage, drug handling, sterilization, final assembly, packaging, storage, serialization, and distribution. By partnering with us as a single provider from our facilities in both Europe and the United States, you gain the advantage of streamlined coordination and expertise, ensuring the successful realization of your products.