Areas of Practice Compliance Support Auditing, Monitoring, 3rd Party Investigations, SOP drafting, Transparency Reporting, Vetting, FDA/OIG Sanction Checks, and more. FDA Consulting Pharmacovigilance, Adverse Event Reporting, FDA Audits, PDUFA Counseling, Marketing Applications, Notice and Comment Rulemaking. Physician Contracting Document Review, Advertising and Promotional Content Support, Drug Labeling and ISI Counseling and Support through Veeva Vault. Legislative & Regulatory Support Life Science Legislative Affairs, Regulatory Rule-making, Tracking Landscape Changes, Drafting Notice & Comment Memorandum, Lobbying. HCP and Physician Agreements, Physician 3rd Party Vetting, State License Checks, Honoraria Reporting, STARK and Anti-Kickback Counseling, HCP Engagement Consulting (PhRMA Code & AdvaMed Code). Medical Legal Review
