Lachman Consultants' 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. We work with our clients to design and implement effective and efficient business processes that assure sustainable compliance-and we do so through optimal integration of scientific, technical, and regulatory principles. Just as important, we help our 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 are proud of what we've accomplished with our clients. The list below provides a high-level overview of the results we've delivered — and how we 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
