Combination products are a rapidly growing segment of the life sciences market. These products combine a drug/biologic component with a medical device component. An example is the drug-coated stent used for coronary angioplasty. But for manufacturers, the convergence of drugs/biologics and devices also brings a host of quality assurance and regulatory challenges.
Only Microtest has the facilities and regulatory experience to offer single-source combination product solutions that reduce risk and cost, while accelerating time to market. Our exceptional project management gives you a single point of contact and accountability. With Microtest’s highly transparent process, you get immediate access to information and project stay on schedule and on budget. And our deep regulatory experience helps you navigate the complexity of two FDA quality systems.
Microtest’s comprehensive combination product solutions include: