Mark Gardner, Gardner Law, Medico-Legal Experts
Gardner Law, PLLC provides legal and regulatory counsel to the medical technology, pharmaceutical, and biotech industries. Our pragmatic and responsive attorneys have worked in industry—which sets them apart from other lawyers. They provide practical advice to leaders across the world navigating the complex healthcare regulatory environment. Gardner Law provides advice at all stages of the product life cycle from ideation, R&D, clinical testing and regulatory submission, to manufacturing and commercialization.
• FDA approval pathways, quality and regulatory assessments
• Healthcare compliance assessments
• Design/implementation of compliance programs, investigations, & training
• Advertising and promotion review
• Interactions with healthcare professionals
• Responding to, and negotiating with, regulators and prosecutors
• Sunshine reporting
• Clinical research
• Privacy matters
Is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.