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.


Pharmaceuticals

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.

Medical Devices

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

Regulatory Compliance

  • FDA and other agency regulatory filings

  • Federal and state government price and transparency reporting advice

  • Legal review of materials requiring PRC/MRC clearance. 

  • cGxP requirements 

  • 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.

Contract Support

  • Private and federal payor rebate agreements

  • Distribution and supply chain strategy and contracting

  • General Transactions:

    • Master Services Agreements and SoWs

    • Clinical Trial Agreements and Informed Consent

    • Business Associate Agreements

    • Professional Consulting Agreements

    • Educational Grants Agreements

    • Sponsorship Agreements

Intellectual Property

  • Patents

  • Trademarks

  • Trade Secrets/Nondisclosure Agreements