As your business partners, we tailor our services and pricing models to meet your unique needs, including offering alternative fee arrangements where we are willing to share some of the risk. Choose any service à la carte or take advantage of our combined legal & regulatory services to provide you with one comprehensive solution.
510(k), Health Canada and EU CE Marking. Handle regulator requests for follow-up information. Extensive experience in submissions for major global markets including Brazil, China, Japan, Russia and more.
Ensure research is compliant with Good Clinical Practices (GCP) and registry requirements. Handle Investigational Device Exemptions (IDEs), Investigational Testing Authorization (ITAs) and Competent Authority Notification submissions. Conduct literature searches and compile clinical evaluation reports (CE Marking).
Draft, negotiate and close a broad range of contracts and transactions, including sales, supply, joint development/collaboration, licensing, distribution, consulting, employment, shareholder, and non-disclosure agreements.
Review promotional materials for compliance with Federal Trade Commission (“fair & balanced”) standards and other applicable laws (non-FDA) and provide trade show support to enable compliant display of new technology.
Get a fresh perspective on how to build and sustain high-performance Legal & Regulatory teams. Does your team work toward a common vision? Do they have clear goals & priorities? Is their mission aligned to the needs of the business they support? Are there any unnecessary gaps or duplication of resources that slow you down or expose you to unknown risks? We provide tailored team coaching and team workshops to help optimize and sustain team spirit and performance.