The medical device industry is experiencing unprecedented merger and acquisition activity. Assessment of potential partners and subsequent integration of development organizations is one of our competencies; we provide clients with certainty regarding their decisions, and facilitate their implementation.
The regulatory approval process is becoming more complex. Global regulatory agencies are implementing fundamental changes to the way they review and approve products. Clinical data requirements are expanding and companies are spending more resources on pre- and post-market clinical programs. Our consultants have extensive experience with clinical regulatory program development and operations, including outsourcing strategy and vendor management.