Compliance Practice

With a team of highly experienced experts from the FDA and industry, Lachman Consultants’ Compliance Practice offers a wide range of mission-critical services to the regulated industry. Lachman works with clients to design and implement effective and efficient business processes that assure sustainable compliance through optimal integration of scientific, technical, and regulatory principles. Just as important, Lachman helps clients stay current with the ever-changing regulatory and technical environment, as well as with evolving industry practices.

Lachman’s Compliance Practice works with a diverse base of companies and is proud of their accomplishments. The list below provides a high-level overview of the results delivered and how Lachman can support your needs as well:

  • Performed third-party oversight for single-site and multi-site consent decree remediation
  • Facilitated the vacating of consent decrees involving sterile and non-sterile products
  • Provided expert consultant services for development and execution of numerous remediation/voluntary corrective action plans, which have been accepted by the FDA
  • Provided numerous due diligence activities during the pre-purchase phase for multinational companies and marketing applications
  • Performed numerous highly specialized audits and consultations under attorney-client privilege
  • Performed numerous application integrity audits
  • Facilitated numerous new facility construction reviews for pharmaceutical clients with the FDA