Delivering accurate results in compliance with requirements

When applicable, we ensure that good laboratory practices are respected and regulatory guidelines are followed.

What is GLP? The GLP acronym stands for Good Laboratory Practice and specifically refers to a quality system of management controls for research laboratories and organization working in preclinical studies. The GLP embodies a set of principles that provides a framework within which laboratory studies are planned, performed, recorded, reported and archived. It assures regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can be relied upon when making risk/safety assessments

Let’s reach your study milestones efficiently

Listed below are some regulatory landmarks for safety pharmacologists.

  1. ICH Guidelines: The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human brings together the regulatory authorities of Europe, Japan, and the United States (S7A & S7B Guidelines).<
  2. FDA/EMEA: The Food & Drug Administration (FDA), Health Canada, the Japanese Ministry of Health and Welfare (MoHW) and the European Medicines Agency (EMEA) subscribe fully to the ICH guidelines.
  3. Good Laboratory Practices (GLP): ICH guidelines S7A & S7B require that safety pharmacology studies be conducted in compliance with current Good Laboratory Practices (GLP) whenever possible.
  4. Electronic Data Management: FDA documents 21 CFR Part 11, entitled “Electronic records; electronic signatures; final rule” is an American FDA guideline intended to permit the widest possible use of electronic technology in drug development.

Animal welfare as a fundamental value

IPST is AAALAC accredited.

AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

More than 1,040 companies, universities, hospitals, government agencies and other research institutions in 50 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC’s program, in addition to complying with the local, state/provincial and federal laws that regulate animal research.

Analysis & guidance included. Always.

Contact us to learn more about how IPST customizes each study design to maximize your strategic and scientific ROI.
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