- Prepared Orphan Drug designation requests for products with pulmonary, antiviral and oncologic indications.
- Prepared comprehensive scientific peer-reviewed report on the status of stem cell transplantation and related therapies.
- Provided assistance with Investigational Device Exemption and Premarket Approval Application submissions in connection with an ophthalmic excimer laser, osteoarthritis device, and wound care product.
- Prepared Investigational New Drug Applications to the United States and Canada for a novel drug delivery system and investigational drug.
- Prepared 510(k)'s and special 510(k)'s on behalf of a variety of U.S. and non-United States medical device companies.
- Prepared and coordinated scientific support for prescription to over-the-counter switch of allergy relief drug product.
- Successfully developed scientific strategies and support to appeal FDA decisions regarding products involving novel delivery systems; osteoarthritis, cardiovascular, neurovascular and dental indications; and tissue transplantation.
- Obtained FDA concurrence on regulatory pathway for the first direct to over-the-counter in vitro diagnostic device and the first third-party 510(k) review for a high-level disinfectant.
- Assisted in due diligence evaluations for a number of successful financings and acquisitions.