Helping Clients Ensure Regulatory Compliance and Scientific Integrity in the Conduct of Nonclinical Safety Studies
Nonclinical toxicology studies can be a major financial investment for businesses, so it is crucial that these studies are well designed and executed to achieve success, and adhere to regulatory requirements.
Companies are responsible for ensuring the regulatory compliance of their studies, and that these studies are conducted with high scientific integrity.
On-site monitoring of these studies can be time- and resource-consuming, requiring experience and attention to detail. Without this oversight, companies run the risk of incurring delays and additional costs. This is particularly important for larger and more complex studies, which have many moving parts, and high costs. During critical study events, an on-site Study Monitor can identify potential issues and facilitate resolution of problems should they arise.
“The Intertek Advantage”
Choosing Intertek means partnering with seasoned professionals who understand the intricacies involved in the conduct of nonclinical toxicology studies. Our team of experts help to ensure that your studies meet regulatory expectations (considering GLP compliance), and that these studies are conducted to the highest standards of scientific integrity.
- Extensive Industry Experience: Our study monitoring team has >50 years of expertise in nonclinical toxicology oversight globally (U.S., Canada, UK, Europe, China, India, Japan), who have collectively monitored well over 100 studies involving a wide variety of study types, species, routes of administration, molecule types, and regional compliance requirements
- Commitment to Regulatory Compliance: Years of experience in a GLP environment are applied to the on-site monitoring of nonclinical studies.
- Accurate and Comprehensive Reporting: Detailed, clear, and fit-for-purpose monitoring reports for the sponsors records.
- Dedicated Consultation and Support: Expert advice throughout your drug development’s lifecycle.
Our breadth of experience has equipped our team with the necessary expertise and skills to navigate the complexities inherent in diverse study types and monitor them effectively.
Overview of Intertek’s Monitoring Experience
- Geographical locations: U.S., Canada, UK, Europe, China, India, Japan
- Study Types: Pharmacology, Safety Pharmacology, General Toxicology, Genetic Toxicology, DART, etc.
- Regional Regulatory Compliance: U.S. FDA GLP, OECD GLP
- Routes of Administration: PO, IV (bolus, infusion), subcutaneous, topical to intact skin, topical to wounds, intranasal
- Molecule types: Small molecule, biologicals (peptides, proteins, and conjugates), foods of varying types (HMO’s, bacteria, botanical extracts, food enzymes, food additives), etc.
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