Global Services & Solutions
Comprehensive Capabilities. Proven Experience.
Lachman offers a full portfolio of FDA compliance consulting, regulatory, and science & technology capabilities to deliver measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by the the FDA.
FDA Related Services
Lachman Consultants offers FDA-related services to clients, such as 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.
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Virtual Inspections
A facility, GMP, pre-approval, or other form of inspection is one of the most important steps in your drug approval process. Lachman Consultants has extensive experience conducting Virtual FDA Inspections to assist with proof of compliance and vital data.
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Due Diligence Audits
Lachman Consultants completes due diligence audits to support strategic mergers and acquisitions.
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Quality Assurance and Controls
Lachman Consultants provides clients with quality assurance and control offerings, such as evaluation of written procedures and standard operating procedures, development of laboratory systems and specifications, corporate oversight programs, and more.
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Scientific and Technical Assistance
Lachman Consultants provides clients scientific and technical assistance to resolve complex problems, including a review program for data integrity, as well as other significant scientific and technical challenges.
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Systems Evaluation
Lachman Consultants offers systems evaluation services, such as R&D manufacturing systems assessments, as well as reviews and recommendations for quality control/quality assurance systems.
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Facilities Design and Evaluation
Lachman Consultants offers clients facilities design or validation services, including a full complement of capabilities from development of requirements to auditing during construction and installation.
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System Process Validation or Qualification
Lachman Consultants offers system and process validation or qualification services, including programmatic assistance, computer system validation, and specific validation/qualification activities.
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Training
Lachman Consultants provides training services, including programs to address compliance and regulatory affairs, as well as custom programs to meet specific requirements.
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Remote Services
Lachman Consultants is supporting our clients with the same expertise, knowledge, and partnership you experienced before “social distancing” became the most spoke phrase in the English Language.
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Lachman OnCall
Now you can speak to one of our Subject Matter Experts and get the answers you need on any of the life science areas that Lachman Consultants serves. Whether it’s something you need to know about compliance, or a complex scientific or technical issue, Lachman OnCall can provide you with the information you need in a matter of hours. Not days or weeks.
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See Our Practice Groups
Lachman Consultants Practice Groups collaborate extensively to ensure that problems entrusted to us are addressed from all angles, consistently delivering thoughtful, comprehensive and effective solutions.
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