Integrated Clinical Bioequivalence and PK Program
Intertek collaborates with Phase 1 clinics in the EU, to provide generic and drug delivery clients with an integrated bioanalytical and clinical testing program for both pilot pharmacokinetic and pivotal bioequivalence studies.
This program combines Intertek’s BioClin laboratory analytical expertise with European Phase 1 clinics to provide a rapid and cost-effective clinical pharmacology service. Intertek partners and operates as a single vendor to provide speed and flexibility, including interim data reporting and real-time, secure web-based data access during the clinical trial.
Intertek BioClin partners with a number of preferred international clinical partners. This joint service provides clients with an opportunity to access the regulatory benefits of conducting clinical pharmacology studies in Europe and streamline the submission process, in both Europe and the US.
Integrated Clinical BE and PK Services:
- Bioanalytical (GLP)
- Assay validation
- Clinical & Preclinical Pharmacokinetics
- Clinical batch stability
- CTA Submission
- ICH integrated reports
- IMP import and QP release
- Pharmaceutical analysis (cGMP)
Bioanalytical services:
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