Food and Drug Law Product Offerings

A Law Practice specializing in Food and Drug Law

For New Ventures in Health Care

  • Assess Regulatory Options, US and Global:

    • For any new medical product, drug or device, the first question is always; “Will it work?” As soon as the answer is “maybe”, you should consider regulatory options for testing and marketing product. Often, the most obvious regulatory pathway may not be the optimal one.

  • Product Development Planning:

    • Global regulatory strategy, clinical trials planning and submissions. For drugs, patent term extension and exclusivity strategies. For combination products, determination and establishment of best regulatory pathway.

  • Joint Development Agreements

    • Contract drafting, review, and consultation.

For Companies Selling Health Care Products

  • Due Diligence for Joint Ventures:

    • Assess your prospective partners’ ability to provide material for submissions, quality of developmental data, and compliance with regulatory requirements for designing, testing and building regulated product.

  • Submissions

    • Training for regulatory staff, review of submissions, construction of submission shells, and with associates, submission writing. Capabilities for IND, IDE, 510(k), PMA, NDA (CMC), Technical File, EU Clinical Trial Notice, patent term extension, suitability petition, request for designation, and others.

  • Compliance

    • Review existing systems, develop new ones, integrate new requirements into older systems, and audit. Management training for executive management.