Toxicology Services Overview
At QACAL Technology, we understand the importance of evaluating the toxicity and safety of biopharmaceuticals, therapeutic proteins, chemicals, active pharmaceutical ingredients, and components.
QACAL Technology has a unique staff base to accommodate your toxicological needs. Dr. Wendy Haines, a board certified toxicologist, is the Director of Toxicology & Quality Services and her and her team look forward to the opportunity to collaborate with you to provide toxicological technical support ranging from categorizing active pharmaceutical ingredients to addressing safety impact of extractables & leachables (E&L).
Toxicological Product Risk Assessment
QACAL Technology’s Toxicology services division offers a comprehensive solution for conducting risk assessment of therapeutic and excipients. Risk assessments are conducted to categorize a product to prevent recalls and ensure patient safety; worker safety; pharmaceutical cleaning limits; and an overall banding characterization of a product. Our board-certified toxicologist and team have conducted more than 350 toxicology risk assessments and banding for both contract manufacturers and owner companies with pharmaceutical therapy and biotechnology products.
Extractables & Leachables (E&L)
QACAL Technology consultants will work alongside you to evaluate your manufacturing process, container closure systems (CCS), and packaging to assess materials and contact chemicals that have the potential to produce extractables and leachables (E&L), to ensure that the product safety, strength, quality, or purity is not altered.