Noreen counsels pharmaceutical and medical device companies on a wide variety of FDA regulatory issues. She has in-depth knowledge of federal regulations governing the FDA application process, the conduct of clinical trials, product labeling, adverse event reporting and analysis, promotional claims, regulatory inquiries, and the external communication of medical information. In addition to her counseling practice, she assists clients with the preparation of SEC filings and conducts due diligence in conjunction with securities offerings and mergers and acquisitions. Her practice also includes the defense of pharmaceutical companies in civil and criminal actions and government investigations.