We engage our clients to gain a deep and clear understanding of their needs. This rigorous discovery process serves as the starting point to develop solutions that deliver for the client and meet the requirements of the regulatory agency. Consultants use a consistent set of tools to solve your problems, consider an exhaustive range of factors to manage risks and unearth opportunities for the customer.
Areas of Expertise
Consultants develop a regulatory path that manages business risks and supports long-term company growth.
Compliance & Change Management
Ulmer Ventures consultants 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.
We prepare the company for effective interactions with FDA. We focus the interactions on getting the answers you need for clearance or approval.
Interim Executive Leadership
We offer short-term roles for senior consultants to deliver on specific key business needs.
At Ulmer Ventures, experienced consultants evaluate potential acquisition targets for robust regulatory submissions, quality management systems, and compliance.
Training & Education
Experienced consultants build customized 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.
Use the form below to contact us regarding your needs. Please be as detailed as possible. Include your industry along with any specific document requests. To help us provide excellent service, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email to make an appointment.