Life Science Strategies
Navigating Compliance, Transforming Life Science
Areas of Expertise
Physician Contracting
Physician Employment Agreements, MGMA Compensation Analysis, Advisory Board Contracts, Clinical Trial Contracts, Physician 3rd Party Vetting, State License Checks, Open Payments Reporting, STARK and Anti-Kickback Counseling, HCP Engagement Consulting (PhRMA Code & AdvaMed Code), and more.
FDA Consulting
Pharmacovigilance, Adverse Event Reporting, FDA Audits, PDUFA Counseling, Marketing Applications, Notice and Comment Rulemaking.
Advertising & Promotion
Regulatory Review, Promotional Review Committee, Medical Legal Review, Advertising and Promotional Content Support, Marketing Compliance and Consulting (Drugs, Devices, Supplements), FDA & FTC Guidance, Compliant and Ethical HCP and Patient Engagements.
Compliance Support
Auditing, Monitoring, 3rd Party Investigations, SOP drafting, Transparency Reporting, Vetting, FDA/OIG Sanction Checks, Conflicts of Interest, Risk Mitigation, Regulatory Compliance, and more.
Legislative & Regulatory Support
Life Science Legislative Affairs, Regulatory Rulemaking, Tracking Landscape Changes, Prescription Drug Affordability Boards, Drafting Notice & Comment Memorandum, State & Federal Lobbying.