With you every step of the path…
You’ve developed a very promising new drug. Congratulations! But now you’re looking at co-developing a novel delivery device and moving this combination product quickly through clinical trials and regulatory approvals. We’re here to keep you on track during each step of the journey.
Combination PRoduct Expertise
CP Pathways has over 20 years of experience in bringing multiple combination products to market. We'll bring the regulatory expertise you need to ensure swift and successful outcomes.
Get the Advice you need for your team
Combination products with devices used for drug administration must be shown to be safe, effective, perform reliably, and be usable. CP Pathways has the experience to interpret what regulators are looking for - in performance testing programs, control strategies, and in human factors testing.
Hope is not the best strategy
CP Pathways’ submission content strategies are informed by hundreds of interactions with the FDA and other Health Authorities. Let CP Pathways customize your submissions to meet the increasingly complex expectations for your products. Craft the responses to FDA reviewer questions that satisfy their technical, safety, and clinical concerns and best explain the rationale for your approach.
Are you ready for the new EU regulations?
Baffled by the new combination product regulations in Europe? CP Pathways’ insights, based on prior successful MAAs, can be leveraged to help you meet the EU’s new MDR Article 117 requirements.
Devices aren’t drugs
Delivery devices and drugs are developed differently and yet all regulatory and development staff need a common understanding of their similarities and what is uniquely different. Let CP Pathways guide you in building a combination product regulatory culture that unites the best of biopharma and device strategies and people. Implement a plan that gets everyone on board.
Take the first step
We’ll work with you to assess your product, strategies, team and timelines and develop a package that suits your needs. We know autoinjectors and pens, pre-filled syringes, transdermal patches, nasal sprays, and more.
We’re excited to explore ideas, help you execute your plans and navigate the paths of an ever-changing world of combination products and regulatory processes.