Laboratory Description:
To support your products in today's complex global marketplace, you need an approach that is tailored to your unique product and distribution strategy. WuXi AppTec has supported hundreds of thousands of devices with the strategies and testing needed to gain market access, avoid costly delays and support changing requirements throughout a product's lifecycle. How do we do this? By focusing our efforts on the following three areas.
Robust ApproachWe're the chemistry gold standard, with the only program committed to doing complete characterization the first time and every time. We meet biocompatibility systemic endpoints with chemical characterization and risk assessment 80-85% of the time.
Active Leadership
We share our knowledge with the FDA on how to approach Biological Evaluations based on International Standards, because we serve on standards committees and track regulatory inquiries and trends. It's what gives us the inside track to be proactive partners that anticipate change.
Strategic Partnership
From development through commercialization, we're your full-service partner and strategic consultant, and true extension of your team.
