Areas of Expertise
Regulatory Strategy development
We develop a regulatory path that manages business risks and supports long-term company growth.
compliance & Change Management
We conduct an assessment of the regulatory and business risk and provide comprehensive solutions. We proactively manage risks that accounts for patient safety, product quality, customer retention, on time delivery, and regulatory compliance. We provide concrete action plans to manage change in the form of reorganization, employee engagement, or crisis management.
fda communication review
We prepare the company for effective interactions with the FDA. We focus the interactions on getting the answers you need for clearance or approval. Specific support includes: FDA response review, meeting preparation, meeting representation.
interim executive leadership
We offer short-term roles for senior consultants to deliver on specific key business needs.
We evaluate potential acquisition targets to identify gaps in regulatory submissions, quality management systems, and compliance.
TRAINING & EDUCATION
We provide lectures to Universities and Corporations on topics related to medical device development. Our focus is on the practical realities involved in bringing a technology from concept to the production-level product. The training and educational opportunities are delivered through webinar, classroom setting or intimate round table format.