DRUG & BIOLOGICAL PRODUCTS

Greenleaf’s Drug and Biological Products Team has a robust blend of regulatory and policy expertise and FDA institutional knowledge. The team’s approach, firmly grounded in established principles of public health, is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.

Greenleaf experts specialize in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements. In addition, the team monitors and analyzes the regulatory environment for emerging trends, agency actions that could potentially impact current development programs, and changes to the competitive landscape for specific therapeutic areas.

Experts from the Drug and Biological Products Team also provide advisory services that include extensive research and due diligence for investors engaged in potential mergers and acquisitions that require regulatory risk analyses before and after decisions and transactions.

Greenleaf’s Drug & Biological Product Services

Product Lifecycle Management

Strategic consultation on:

  • FDA regulatory programs and procedures
  • Product development
  • Premarket review
  • Postmarket safety requirements
  • Market analysis for potential competition

Premarket Review Process

Effective guidance on:

  • Scientific and regulatory practices for clinical programs and regulatory submissions
  • Preparation for FDA meetings, including advisory committees
  • FDA communications, including formal, in-person, and regulatory correspondence

Marketing & Promotional Practices

Skilled support on:

  • Labeling requirements
  • Promotional materials
  • Direct-to-consumer advertising review processes
  • Remediation of untitled and warning letters
  • Use of social media

Regulatory Policy Guidance

Specialized insight on:

  • FDA policies and procedures
  • User fee requirements
  • Advisory committee decisions and meeting preparation
  • Implementation of new FDA legislation, regulations, guidance documents, and FDA standard operating procedures

Drugs Team Members