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Integrated Clinical Bioequivalence and PK Program

Industries serviced: Medical & Pharmaceutical

Send us a request

E-mail Us

webinfo.as@intertek.com

Call Us

EU (IRE):+353 90 646 0200

Pharmaceutical

• Global Pharmaceutical Services
• Pharmaceutical Services A-Z Listing 

Intertek BioClin

IDA Business & Technology Park
Garrycastle
Athlone
Co. Westmeath
Ireland

Download details on:
Location (PDF 12 KB)

Validated Assays

View a full list of validated assays from Intertek BioClin, Ireland. (153 KB PDF)

Shandon Clinical Trials Ltd

Learn more at www.shandonclinic.com

Intertek's BioClin laboratory based in Ireland 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 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.

In Ireland, the preferred clinical partner is Shandon Clinical Trials Ltd. based in Cork.  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

• Assay validation
• Bioanalytical (GLP)
• Clinical batch stability
• CTA Submission
• ICH integrated reports
• IMP import and QP release
• Pharmaceutical analysis (cGMP)
• PK, statistics, protocol design
• Phase 1 clinical conduct

Request more information to see how Intertek can help your organization with Integrated Clinical Bioequivalence and PK Program.