Articles, Pharmaceutical

Analysis of drugs that ALS Life Sciences São Paulo offers

We offer non-clinical studies for the safety assessment of synthetic, herbal, biological and biotechnological pharmaceutical products. The studies offered are conducted in accordance with Good Laboratory Practice (GLP) – OECD Principles of Good Laboratory Practice, are recognized by CGCRE* (General Coordination of Inmetro Accreditation) and ANVISA (Reblas) and follow the recommendations of the “Guide for the Conduct of Non-Clinical Studies in Pharmacological Toxicology and Safety Necessary for Drug Development” of ANVISA (2013).

The protocols meet the requirements of agencies recognized by the sanitary surveillance of drugs (FDA, EMA), and institutions of interest in the area (ICH, OECD, NCI, WHO).

Portfolio of work

  • Non-clinical studies of acute toxicity;
  • Non-clinical studies of subchronic toxicity;
  • Irritation studies;
  • Awareness-raising studies;
  • Local tolerance studies;
  • Ames test;
  • Micronucleus Testing.

Accreditations

  • BPL
  • CGCRE (General Coordination of Accreditation of Inmetro)
  • ANVISA

Applications

Guide to Conduct Non-Clinical Toxicology and Pharmacological Safety Studies Required for Drug Development. ANVISA (2013).

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