Newsletter | March 24, 2021

03.24.21 -- Addressing The Challenges Associated With The Development And Commercialization Of Combination Products

Trends In Combination Products

As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Recent FDA and ICH guidances have clarified expectations from both a developmental and commercialization standpoint. When producing drug/device combination products, three major regulatory themes arise.

Selecting Your Combination Device Partner

Collaborating with the right device contract manufacturer can improve the likelihood for success with your combination product or drug delivery device system. It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.

Maximize Global Regulatory Collaboration For Combination Products

When marketing a combination product globally, it is important to have a collaborative relationship between pharmaceutical manufacturers and drug delivery technology providers. To successfully work together, the two parties must have a cooperative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement.

Minimizing Uncertainty Throughout The Development Life Cycle

Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability and end-user needs in mind, and all the delivery system elements must comply with the highest quality and regulatory standards. Learn how to create a smooth device development pathway, building an integrated plan that captures and manages interdependencies throughout the life cycle.

Create An Effective Risk Management Program

Drug-device combination products are rapidly increasing in use, due to their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.

The Importance Of An Analytical Testing Strategy

Combination products have become more complex because of advancements in drug formulations, container technologies, and related materials — all of which are often independently designed and developed. Having the proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.

How can you de-risk your product development?

The drug development path is complex. From regulatory strategy, analytical testing, and manufacturing, to supply chain. You need a partner that understands your challenges and can work with you to build an integrated plan that captures the interdependencies and can manage them throughout the product life cycle. Gain insights on ways to:

  • Reduce development and supply risk
  • Accelerate your path to market
  • Improve the patient experience

 Download our exclusive services and solutions roadmap.