If you’re an executive in the pharmaceutical or medical technology industries, the regulatory hurdles you face may seem daunting. We can help you manage regulatory risk and meet compliance mandates with confidence, so you can move your business forward.

Gardner Law is your full-service regulatory advisor with the real-world knowledge and can-do attitude to get the results you need.

Contact us today.

Mark GardnerO: 651.430.7150 | M: 612.382.7584

Specializing in Medical Technology and Pharmaceutical Laws and Regulations

A P R O V E N P R A C T I C E W I T H Y E A R S O F E X P E R I E N C E I N:

+ C O M P L I A N C E

+ A D P R O M O R E V I E W

+ S U N S H I N E /A G S P E N D

+ E N F O R C E M E N T

+ R E G U L AT O R Y

+ Q UA L I T Y M A N A G E M E N T S Y S T E M S E R V I C E S

+ C L I N I C A L

+ P R I VA C Y

G A R D N E R.L AW

COMPLIANCELet our team lead or assist your Compliance function and advise you on laws, regulations and rules related to marketing, sales, reimbursement, and clinical research, as well as Quality Management System regulations.

AD PROMO REVIEWReceive counsel on the labeling, advertising, and promotion of FDA-regulated products, such as pharmaceuticals, medical devices and diagnostics.

SUNSHINE/AG SPEND We will help you stay compliant with new transparency requirements, and assist you with submissions required by the Physician Payments Sunshine Act and strict state laws.

REGUL ATORY SUBMISSIONS Trust us to represent you at FDA meetings and make accurate submissions to the government.

ENFORCEMENT ACTIONSDealing with an FDA or DOJ enforcement action? Our team can help you defend your case and protect your business.

QUALIT Y MANAGEMENT SYSTEMOur experienced team can assist with system development, gap analysis, documentation development, process improvement/optimization, process automation, external audit finding resolution, and internal audit coordination.

CLINICAL SERVICESWe offer you extensive experience in dealing with clinical activities.

PRIVACYWe help companies determine how HIPAA impacts their business and how to protect patient health information in accordance with the Privacy Rule among other requirements.

GARDNER L AW HELPS YOU

Manage regulatory risk and reach your business goals

G A R D N E R.L AW