Overcoming Regulatory Challenges For A Complex Product

Cardinal Health Regulatory Sciences partnered with a client to help them navigate the complex regulatory requirements for their new medical device. The team addressed challenges related to the client's foreign entity status, unique technology, and combination product features. They provided regulatory dossiers, conducted audits, and facilitated meetings with the FDA to ensure compliance and obtain FDA approval. Cardinal Health Regulatory Sciences also provided ongoing support and training to the client, particularly in the area of aseptic processing and sterilization challenges.

Explore this case study to dive into the details of how the product successfully received FDA approval, allowing the client to market it in the US.