Alexandra advises a wide variety of clients in the life sciences sector. She assists clients with risk assessments, corporate and commercial compliance program development and implementation, internal investigations and industry operational strategies. She also advises on U.S. Food and Drug Administration (FDA) regulatory, compliance and enforcement issues.
- Developing policies and procedures designed to allow small start-up and mid-sized pharmaceutical companies to implement corporate and healthcare compliance programs in alignment with the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers.
- Counseling clients, based on specific business operations and complex organizational structure, on the applicability of the Open Payments reporting requirements of the Patient Protection and Affordable Care Act and related state laws.
- Conducting investigations related to the appropriateness of interactions between commercial and medical departments, and company interactions with healthcare practitioners.
- Counseling clients, based on specific business operations, on the applicability of state specific pharmaceutical manufacturer and distributor licensure and permit requirements.
- Assisting clients in the preparation and filing of trademark applications with the United States Patent and Trademark Office.
- Counseling clients on the regulatory requirements with respect to charging for Investigational New Drugs (INDs).
- Assisting clients with the generation and submission of 510(k) Applications and European Union Design Dossier files.
- Jamie Kendall, Brad Welsh & Alexandra Schulz, Trump’s Push for Direct Medicare Drug Price Negotiations Addresses Only One Piece of the Industry’s Drug Pricing Puzzle, United States Biopharmaceuticals 2017, Global Business Reports, May 2017, at 25, available at http://gbreports.com/wp-content/uploads/2017/05/US-Pharma-2017-Web-Preview.pdf.
- Jamie Kendall & Alexandra Schulz, Why Patient Experience Data Provisions Face Elimination, Law360, (Mar. 22, 2017), https://www.law360.com/articles/904561/why-patient-experience-data-provisions-face-elimination.
- Jamie Kendall & Alexandra Schulz, What First Amendment? FDA Remains Unfazed By Off-Label Communication Issues, Pharm Exec.Com (Mar. 7, 2017), http://www.pharmexec.com/what-first-amendment-fda-remains-unfazed-label-communication-issues.
Alexandra earned her Juris Doctor from Villanova University School of Law where she was awarded a Dean’s Merit Scholarship. While in law school, Alexandra worked as a legal intern in the pharmaceutical industry where she assisted in-house counsel on numerous tasks and responsibilities including actual and perceived risk mitigation strategies. Alexandra earned her B.A., cum laude, in history from Wake Forest University and is admitted to practice in Pennsylvania and New Jersey.