Lachman’s Science and Technology Practice is an integral part of the company’s success. Working hand in hand with Lachman’s Compliance and Regulatory Affairs practices, the Science and Technology Practice works efficiently and effectively to address issues with a thorough and balanced approach. With an intimate understanding of the complex scientific and technical challenges clients face, the Science and Technology Practice is able to provide recommended solutions that are scientifically and/or technically accurate—and eminently actionable within clients’ operations.
In one way or another, the Science and Technology Practice’s work touches virtually every client Lachman Consultants serves. The Lachman Science and Technology Practice is particularly proud of these achievements:
- Developed comprehensive quality control laboratory training and qualification courses/programs
- Developed specialized laboratory data integrity investigative techniques to audit analytical raw data (including electronic source data) to ensure accuracy and validity
- Provided expert scientific guidance to understand and resolve significant issues related to adverse FDA 483 observations and warning letters
- Developed specialized and effective auditing techniques in support of numerous “for cause” audits of GMP, GCP, GLP, and BE/BA bioanalytical laboratories
- Developed specialized training and technical publications
- Provided expert scientific support for the timely resolution of complicated scientific issues raised by FDA application reviewers