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Greenleaf Health consults on strategic regulatory matters for a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical device companies that develop innovative solutions to pressing public health challenges around the globe.

Click here to download more information about Greenleaf Health’s people and consulting services.

Greenleaf provides regulatory guidance on issues that include, but are not limited to:

Product Lifecycle Management

  • Strategic guidance regarding the FDA review process
  • Post-market safety requirements
  • Assessing generic competition

Product Approval

  • Strategic approach to filing
  • Analyzing Complete Response Letters
  • Preparing for FDA Advisory Committee meetings

Product Labeling

  • Strategic guidance on new labeling requirements
  • Strategic guidance on labeling negotiations
  • Risk Evaluation and Mitigation Strategy (REMS) safety plans

Marketing and Promotional Practices

  • Direct-to-consumer (DTC) advertising review process
  • Remediation of untitled and warning letters
  • Use of social media

Regulatory Policy

  • Implementation of FDA’s Biosimilars program
  • Generic drug user fee requirements
  • FDASIA implementation
  • FDA policies and processes
  • FDA Advisory Committee analysis

Manufacturing and Compliance

  • FDA inspection process
  • Assessment of Form 483 and EIRs
  • Current Good Manufacturing Practices (cGMPs) deficiency letters
  • Corporate warning letters

Learn more about the Greenleaf Enforcement Team and Services.

Read about Greenleaf’s 2013 Enforcement Report here.