Comprehensive Capabilities. Proven Experience.
When it comes to compliance and regulatory affairs, Lachman Consultants has set the industry standard. Since 1978, we have been delivering measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by FDA. Today, we offer a full portfolio of capabilities:
FDA-Related Services - including document preparation/reviews, audits and reviews, compliance problem resolution, training, regulatory affairs strategic assistance, preparation and/or review of regulatory filings, and other special services specific to our clients' needs
Due Diligence Audits - to support strategic mergers and acquisitions
Quality Assurance and Controls - including evaluation of written procedures and standard operating procedures, development of laboratory systems and specifications, corporate oversight programs review and enhancement, and more
System and Process Validation or Qualification - including programmatic assistance, computer system validation, and specific validation/qualification activities
Scientific and Technical Assistance - resolution of complex problems including a review program for data integrity, as well as other significant scientific and technical challenges
Systems Evaluation - including R&D manufacturing systems assessments, as well as reviews and recommendations for quality control/quality assurance systems
Facilities Design and Validation - including a full complement of capabilities from development of requirements to auditing during construction and installation
Training - including programs to address compliance and regulatory affairs, as well as custom programs to meet specific requirements
Support Services for Law Firms - including provision of expert testimony on FDA policies, procedures, and precedent to assist with product liability, patent, or exclusivity-related litigation
