Gardner Law specializes in pharmaceutical and medical technology law. Our team provides pragmatic and responsive advice to leaders navigating today’s healthcare regulatory minefield.


Program design and operation
Policy development and training
Opinions and audits

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Ad Promo Review

Legal and Regulatory review
Social media, SEO and paid search
Product launch review

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Sunshine Reporting

Reporting outsourcing
Gift ban policy creation and training
Competitive intelligence

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Regulatory & Quality

Approval pathway assessments
Premarket application submissions
Quality auditing and remediation

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Responding to regulators
FDA litigation
Competitive complaints

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Clinical trial agreements
Research grants and payments
Investigational regulations

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HIPAA auditing
Policy development and training
Patient support program auditing

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Regulatory Alert:

Important 2019 FDA Medical Device Guidance Documents.

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Regulatory Alert

Seeking FDA Emergency Use Authorization for a COVID-19 medical device

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