Ensuring your product is accepted by regulatory authorities, compliant with classification, labeling and safety standards, and up-to-date with the latest regulatory changes is a complex process that requires extensive insight on current guidelines.
Physicochemical characteristics determine your chemical's testing requirements and regulatory pathways, so it's important to tailor your product chemistry analysis to address your specific needs and avoid delays.
The transformative Labcorp approach is based on an operating model enabled by continuous innovation across our infrastructure. The result is real-time access to clinical trial data, allowing proactive mitigations and confident decisions, faster.
Literature reviews offer a cost-efficient approach to appraise the currently published literature to gather evidence, address potential data gaps and support downstream market access activities.
Immunogenicity assays that are developed and validated to support preclinical studies are often validated in the same way as clinical assays, even though the purpose of the data is very different.
We were approached by a client about an older substance originally registered under Notification of New Substances (NONS), but assessed under Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation.
Health economic analyses complement the existing clinical evidence base to support a product's value proposition. This additional evidence helps to support the case for unmet need (cost of illness), affordability and value for money.
