Bio-Assistance
Your partner in new drug R&D
Work in the lab (an illustration)

Design and implementation of Good Laboratory Practices

To attain compliance with Good Laboratory Practice (GLP) for Non-clinical Laboratory Studies imposed by the US Food and Drug Administration (21 CFR, Part 58) and Organization for Economic Cooperation and Development (OECD), Bio-Assistance offers to academic and research laboratories support in the

  • Preparation of documentation system, such as manuals, policies, plans, system documents, Standard Operating Procedures, or forms that will define and assure compliance with the regulations identified above,
     
  • On- and off-site project management activities that will ensure implementation of those directives to attain compliance with GLP and
     
  • On-site verification of the compliance through external and self audits