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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We relied upon Gardner Law to provide us with an exceptionally high quality out-sourced compliance function that was seamlessly up and running almost overnight.
– Thomas McCracken, former VP, General Counsel, Secretary and Compliance Officer of a publicly-traded pharmaceutical company

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