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.
Areas of Expertise
Regulatory Services
Lead implementation of strategy and design requirements for market access. Prepare teams for meetings with Notified Bodies, FDA and other regulators.
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.
Create strategy for claims substantiation. Review promotional materials for compliance with FDA standards.
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).
Evaluate regulatory compliance for M&A transactions – from due diligence analysis to post-closing integration related to product registration amendments.
Facilitate FDA establishment registration & device listing.
Legal Services
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.
Deep healthcare expertise in medical device and life sciences, including anti-kickback and FDA pre-clearance activities.
Advise on all aspects of M&A transactions to facilitate the deal – from due diligence analysis, contract negotiation, to post-closing integration.
Counsel on all stages of growth, from formation, financing and capitalization, to exit strategies (acquisition, license, IPO etc).
Joint development/collaboration agreements, licensing transactions (inbound & outbound), and pilot contracts.
Help optimize your compliance strategy by identifying key risk areas and providing pragmatic solutions for addressing them via smart risk management and right-size compliance strategies.
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.
Handle legal entity formation, Board of Director and shareholder meetings, and general corporate maintenance.
Custom-Fit Offerings
Optimize your legal & regulatory strategies by identifying key risks and improvement opportunities and assessing regulatory strategy for market access in U.S., EU, Canada and other key markets.
Conduct legal & regulatory due diligence analysis for an acquisition or financing.
Empower your teams with our training on the latest industry and enforcement trends designed to provide you with pragmatic ‘dos and don’ts’.
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.