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

Compliance

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

Approval pathway assessments
Premarket application submissions
Quality auditing and remediation

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Enforcement

Responding to regulators
FDA litigation
Competitive complaints

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Clinical

Clinical trial agreements
Research grants and payments
Investigational regulations

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Privacy

HIPAA auditing
Policy development and training
Patient support program auditing

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January
Regulatory Alert:

Important 2019 FDA Medical Device Guidance Documents.

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April
Regulatory Alert

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

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