Research
Bioequivalence and Clinical Research (CRO)
We plan and run bioequivalence and pharmacokinetic studies for pharmaceutical companies, from protocol design and ethics approval to clinical conduct, bioanalysis, statistics and the final study report.
A generic medicine cannot be registered until it is shown to behave in the body like the reference product.
We plan and run bioequivalence and pharmacokinetic studies for pharmaceutical companies, from protocol design and ethics approval to clinical conduct, bioanalysis, statistics and the final study report.
Terms and conditions apply. Read the terms
Who it is for
Generic manufacturers preparing a registration file, and sponsors who need pharmacokinetic data on a new formulation.
What you receive
- Study design and protocol written to the reference product and the target regulator.
- Ethics committee and regulatory submissions, and follow-up until approval.
- Volunteer screening, dosing and sample collection under a written clinical plan.
- Bioanalysis of every sample on a validated LC-MS/MS method.
- Pharmacokinetic and statistical analysis (Cmax, AUC, 90% confidence intervals).
- A final study report formatted for your registration dossier.
How we deliver it
- Feasibility review of the product and the reference.
- Protocol, quotation and timeline agreed in writing.
- Approvals obtained before the first volunteer is dosed.
- Clinical phase and sample shipment under chain of custody.
- Bioanalysis, statistics and report writing.
- Report delivered, with support for regulator questions.
Related services
Tell us about your product or your samples
We reply with the right method, a timeline and a written quotation. A non-disclosure agreement comes first if you need one.