Regulatory Strategy
Combination products regulations drive many aspects of a development program. When you have novel technology or indication, a comprehensive regulatory strategy can ensure the pathway chosen is optimized for success. CP Pathways can define the testing programs and source documents that your company will need for each development and submission stage. We can develop original strategies for reducing regulatory risk, or conduct a review or rework of existing strategies that will maximize regulatory success. We can support your efforts in meeting with regulators and translate their expectations into practical approaches. We can present in-company seminars on best strategy principles tailored to your product concepts so that designers and executives are on the same page for a path forward.
Doc Submission and Support
CP Pathways can review, edit, or prepare your delivery device-specific content in dossiers using proven approaches and content plans. Using a mix of ICH eCDT-expected content and a dedicated delivery device module, your drug-device combination product will be presented in its best light, balancing the level of detail optimized to minimize post-approval dossier updates. Future MAA submissions to the EMA in Europe will require a Notified Body review, and CP Pathways is current with these challenging new regulatory requirements and the pathway that will be needed.
Due Diligence
If you are a company executive or an investor, CP Pathways can conduct a due diligence review of your product, its regulatory challenges, and the options available for meeting the expectations of regulators. CP Pathways will base its recommendations on its experience in due diligence reviews of FDA feedback in other challenging combination product regulatory scenarios. CP Pathways knows the current regulatory landscape that applies to most combination products and can develop a combination product regulatory strategy that will be understood by high level executives and investors in moving projects forward.