Pharmaceutical Toxicology Consulting
Global toxicology consulting services for the pharmaceutical industry.
Intertek provides expert toxicological and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. Intertek experts with years of industry experience provide solutions to complex development, toxicological, and regulatory issues, through the combined expertise of scientific and regulatory experts located worldwide.
Pharmaceutical Toxicology Consulting Services:
- Design, implementation, and management of nonclinical testing programs with a focus on company goals (e.g. First-in-Human trials and achieving Proof of Concept, Phase II to full market registration support)
- Review, interpretation, and positioning of data (toxicology study reports, literature, safety data)
- Toxicology issues resolution, including interactions with regulatory authorities and the preparation of “White papers”
- Gap analysis and independent data reviews
- Hazard identification and toxicology risk / safety assessments for impurities, excipients, leachables, extractables, etc.
- Pre/Post-marketing toxicology consulting
- GLP study monitoring, including pre-placement and in-life study audits
- Calculate the PDE of your API based on a review and assessment of relevant toxicological and pharmacological data
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