Our Process
KNOWLEDGE BASED
Driven by real time data, Cogentsee provides clients with a hassle-free roadmap to
getting their products to the market. We deliver detailed regulatory support and utilize established relationships
with the regulating bodies in North America, Asia Pacific, Europe, Middle East, Latin America, and Africa to
formulate accurate and precise strategies, submissions, project management; as well as up & reclassification
solutions to meet your needs.
COLLABORATIVE
Cogentsee devises one-of-a-kind strategies that fit specific organizational objectives and
goals that go well beyond a one-size-fits-all perspective. Prioritizing onsite interactions, in-person team
meetings, embracing the company culture, and learning the existing systems equips us to best help the client
exceed their regulatory goals.
FAST TRACK
Always up for the challenge to fast track complex projects to completion with a smile.
Cogentsee uses seasoned expertise in domestic and international regulations, coupled with a foundational
knowledge in engineering, clinical research administration, and natural sciences to advise the best tactical
approach, developmental pathways and compliance solutions.
BEYOND THE FINISH LINE
Much of the work and counsel critical to Cogentsee clients goes far beyond
meeting deadlines, and crossing the finish line. Cogentsee helps medical devices companies align their global
Regulatory, Compliance and Quality needs to effectively serve health professionals, institutions, patients, and
the medical community as a whole.
Contact us to begin your strategic journey.