Science takes time.
If you are finalizing your clinical development protocols, or filing for an Investigative Device Exemption, we know the time it takes to get your product from development to market is crucial to your biotech business’ future success.
We make efficient use of yours.
Whether you need FDA and other regulatory support for your product’s development, strategic insights on bringing your product to market, or contract support with your distribution and payment networks, we can provide scalable legal solutions that help you spend less time worrying about the legal hurdles for your business and more time focused on your innovation.
We understand that early-state pharmaceutical companies are laser-focused on research and business development – using valuable and limited resources on areas that will most efficiently advance those goals. Whether you’re a small post-clinical start-up, or a growing company with products on the market, we can provide affordable, efficient, and practical legal guidance to help with the various FDA and healthcare issues impacting your growing pharmaceutical company.
With an increased focus on access to, and utilization of, innovative technology, medical device companies are currently in a great position to start and grow their businesses. Our strategic guidance can help you wherever you are in your concept to commercialization life cycle. We understand how healthcare providers and suppliers can use some of these cutting-edge technologies in their practices, including the potential revenue streams that these devices can help create in the healthcare marketplace.
Legal Services for Pharmaceutical and Device Companies
FDA and other agency regulatory filings
Federal and state government price and transparency reporting advice
Legal review of materials requiring PRC/MRC clearance.
Anti-Kickback, Anti-Bribery and Corruption, and Patient Privacy
Policies and Procedures
State and federal aggregate spend compliance and training
Compliance program policy review and field team training
Adverse event, product quality, and patient safety reporting.
Private and federal payor rebate agreements
Distribution and supply chain strategy and contracting
Master Services Agreements and SoWs
Clinical Trial Agreements and Informed Consent
Business Associate Agreements
Professional Consulting Agreements
Educational Grants Agreements
Trade Secrets/Nondisclosure Agreements