PRODUCT QUALITY, MANUFACTURING & COMPLIANCE

Greenleaf experts identify and promote practices that will align a client’s approach with FDA’s regulatory expectations. Robust quality management systems help companies to ensure premium-quality ingredients and components, stringent manufacturing practices and processes, and a uniformly reliable supply chain to meet patient and consumer needs.

By analyzing compliance issues and tracking FDA trends, Greenleaf assists companies navigating this new regulatory environment throughout every step in the process.

Experts from Greenleaf’s Compliance Team also provide advisory services that include extensive research and due diligence for firms engaged in potential mergers and acquisitions that require regulatory risk assessments before and after a life sciences transaction.

GREENLEAF'S COMPLIANCE SERVICES

Analysis & Expert Consultation

Greenleaf provides regulatory analysis for strengthening:

  • Corporate quality systems
  • Corporate training programs
  • Corporate compliance strategies
  • Inspection readiness
  • Corporate quality and compliance organization

Regulatory Guidance

Greenleaf provides corporate insight on:

  • FDA inspection, compliance and enforcement processes
  • FDA organization and structure as they relate to compliance functions and decisions
  • Impact of compliance-related legislation, regulations and guidance
  • FDA trends and priorities

Corporate Training & Development

Greenleaf provides training and development for:

  • Issuing technical reports, determining policies and procedures, and revising company SoPs
  • Preparing for FDA meetings and facilitating effective interactions with FDA
  • Training in cGMP, quality system regulation compliance and other compliance-related issues
  • Developing responses to compliance-related proposals
  • Assisting legal counsel on compliance-related issues
  • Engaging with a firm’s inspection team

FDA Communications

Greenleaf provides evaluation and response recommendations for:

  • Facility and supply chain audit reports
  • cGMP deficiency letters
  • Establishment inspection reports (EIRs)
  • FDA Form 483s
  • Warning letters
  • Untitled letters
  • Other compliance- and enforcement-related actions
Download Compliance Services PDF

Compliance Team Members