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Services

Greenleaf Health consults on strategic regulatory matters for a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical technology 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

  • Product development phase
  • Breakthrough Therapy Designation
  • FDA review process
  • Post-market requirements
  • Assessing generic competition
  • Post-approval safety monitoring

Product Approval

  • Clinical trial design and analysis
  • 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
  • Patient labeling

Marketing and Promotional Practices

  • Pre-launch Advisory Comments
  • Direct-to-consumer (DTC) advertising
  • Professional promotion
  • Remediation of untitled and warning letters
  • Use of social media

Regulatory Policy

  • FDA policies and processes
  • FDA Advisory Committee analysis
  • Implementation of FDA’s Biosimilars program
  • User fee requirements (PDUFA, MDUFA, GDUFA, BDUFA)

Manufacturing and Compliance

  • Understanding the FDA inspection process
  • Assessment of Form 483 and EIRs
  • Current Good Manufacturing Practices (cGMPs) deficiency letters
  • Evaluating Warning Letters
  • Effectively communicating with FDA

Learn more about the Greenleaf Enforcement Team and Services.

Read about Greenleaf’s 2013 Enforcement Report here.