Lachman Consultant Services Inc.


About US:

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.

Web Site: www.lachmanconsultants.com
Address:

1600 Stewart Ave.
Westbury, New York 11590
United States
Phone: 516.222.6222
Fax: 516.683.1887
Email: LCS@LachmanConsultants.com

Contact:

Joan Janulis
Vice President

Geographic Areas: Africa
Asia
China
Japan
South Korea
Australia/Oceania
Australia
New Zealand
South America
North America
Business Type: Consulting Services
Products: Biologics
Vaccines
Cellular & Gene Therapy
Combination Product
Cosmetics
Medical Devices
Drugs
Patent Drug/New Drug/Brand Name Drugs
Generic Drugs
Orphan Drugs
Veterinary Medicines
Professional Responsibility (Production): Conception and Development
Research
Manufacture
Manufacturing
Packaging
Labeling
Postmarketing
Reporting
Tracking
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)
Registration Establishment
Other Professional Responsibility: Crisis Management/Risk Management
Employment
Management
Negotiation
Strategic Planning
Training/Education