The RAPS store will be under maintenance Saturday, 28 September between 6 a.m. and 12 p.m. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.
Lachman Consultant Services Inc. (LCS), founded in 1978, is a worldwide leading provider of expert technical, compliance and regulatory services in all FDA-related areas. LCS utilizes a staff of professional consultants including industry experts and former senior FDA officials experienced in regulatory affairs, development, implementation and management of diversified projects. LCS has developed a strong reputation for its unique ability to integrate the multi-disciplinary expertise of its team. LCS has a full range of services, including Compliance audits, Development, Management and oversight of Corrective Action Plans, Application Integrity Policy reviews and audits, Preparation and evaluation of regulatory documents for FDA submission, Technical assistance regarding cGMPs, Electronic Documentation, GLPs, and GCPs, Pre-Approval Inspections and Due Diligence reviews, Manufacturing, Quality Assurance, Laboratory systems and controls, Training Programs, and Research & Development.
1600 Stewart Ave.
Westbury, New York 11590
Cellular & Gene Therapy
Patent Drug/New Drug/Brand Name Drugs
|Professional Responsibility (Production):
||Conception and Development
|Professional Responsibility (Regulatory Process):
||Good Laboratory Practice (GLP)
Quality System (QS)
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
Biological License Approval (BLA)
Investigational New Drug (IND)
Investigational Device Exemption (IDE)
New Drug Approval (NDA)
Premarket Approval (PMA)
Premarket Notification (510k)
|Other Professional Responsibility:
||Crisis Management/Risk Management