Lachman Consultant Services
Lachman Consultants has been providing compliance, regulatory affairs, and science & technology services to clients worldwide since 1978. They are known for their unmatched regulatory insight and experience, offering efficient services with highly qualified professionals. Their mission is to accelerate compliance and approvals in the pharmaceutical, biologic, and medical device industries, ensuring clients confidently navigate complex regulatory landscapes.
Industries
Nr. of Employees
medium (51-250)
Lachman Consultant Services
Westbury, New York, United States, North America
Services
Simulated FDA inspections including facility walkthroughs, document review and inspection-readiness feedback delivered on-site or remotely.
Time-boxed teleconsultations with subject-matter experts for rapid answers to GMP, regulatory or technical questions.
Support for analytical method strategy, laboratory testing and bioanalytical services to support QC and regulatory submissions.
Consulting for biomonitoring program design, execution support and interpretation to meet safety and regulatory needs.
Preparation of regulatory responses and remediation plans addressing inspection observations and enforcement interactions.
Assessments and advisory services for electronic records, data governance and controls as part of digital transformation initiatives.
Simulated FDA inspections including facility walkthroughs, document review and inspection-readiness feedback delivered on-site or remotely.
Time-boxed teleconsultations with subject-matter experts for rapid answers to GMP, regulatory or technical questions.
Support for analytical method strategy, laboratory testing and bioanalytical services to support QC and regulatory submissions.
Consulting for biomonitoring program design, execution support and interpretation to meet safety and regulatory needs.
Preparation of regulatory responses and remediation plans addressing inspection observations and enforcement interactions.
Assessments and advisory services for electronic records, data governance and controls as part of digital transformation initiatives.
Expertise Areas
- Regulatory compliance and strategy
- FDA inspection preparedness and response
- GMP manufacturing compliance for biologics and ATMPs
- CMC and formulation support
Key Technologies
- Cell and gene therapy manufacturing
- Biologics development
- Combination product development
- In vitro diagnostics (IVD)
News & Updates
Lachman Consultants celebrates Robert Pollock, M.S., who received a prestigious lifetime achievement award at AAM’s Access! 2025 conference.
Lachman Consultants will showcase their expertise at The MedTech Conference in Toronto, Canada, October 15-17, 2024.
Lachman Consultants' Charles Gibbons has been invited to speak at the CPhI Global Conference, focusing on navigating data compliance standards in pharma.
Lachman Consultants will participate in Fierce JPM Week, exploring innovation and AI in pharma industry discussions.
Lachman Consultants celebrates Robert Pollock, M.S., who received a prestigious lifetime achievement award at AAM’s Access! 2025 conference.
Lachman Consultants will showcase their expertise at The MedTech Conference in Toronto, Canada, October 15-17, 2024.
Lachman Consultants' Charles Gibbons has been invited to speak at the CPhI Global Conference, focusing on navigating data compliance standards in pharma.
Lachman Consultants will participate in Fierce JPM Week, exploring innovation and AI in pharma industry discussions.