Combination Product Industry News & Guidance

SCI has hired a new Senior Consultant, who has consulted on both sides of the FDA/Pharma regulatory submission table

Suttons Creek is excited to announce our recent hire of Chase Tarnstrom as Senior Consultant on Director, Technical Services Carolyn Dorgan’s team. Like Carolyn, who is a former FDA Reviewer, Chase brings inside knowledge of the Food and Drug Administration. He gleaned insight into the organization’s inner workings, processes and usual review and approval practices during the 3+ years he was contracted as a consultant for the FDA to support successful review of submissions from regulatory divisions of market-leading pharmaceutical companies. Chase also worked directly for Pharma clients, using his FDA know-how to provide strategic direction for real-world evidence utilization and approval facilitation of NDA, BLA, and 510K submissions.

“With experience working both directly for the FDA and then directing pharmaceutical companies through the – what sometimes feels like a labyrinth of the – FDA drug delivery device system approval process, Chase will be a sought-after asset for our clients,” says Dorgan. “He has a strong background in regulatory strategy, real world evidence, risk management, and post market requirements that are in demand for outsourcing by Pharma companies. We are lucky to have him.”

Chase is known by colleagues and clients for his strong work ethic, effective communication, collaborative approach, and commitment to staying updated with industry trends. We are excited to add yet another consultant with such a proven track record for achieving the goals of pharmaceutical organizations navigating regulatory compliance.

Please join us in welcoming him on LinkedIn!