The Expertise
The success of generic pharmaceutical program is often based on timely recruitment and robust protocol design for the bioequivalence study. With its expertise in clinical development process, Probiotech will help your next generic product get to market faster.
Would you like to get approval for your generic product faster?
Probiotech provides a range of services for generics. We focus on bioequivalence studies to ensure rapid study start-up and execution in accordance with GCP guidelines.
Our bioequivalence services include:
- Ensuring regulatory and ethics committee approval
- Validation of assays for measuring the drug and its metabolites in biological samples
- Timely subject recruitment
- Executing the study protocol
- Pharmakinetic and statistical data evaluation
- Reporting of study results
- Closing out the study and ensuring records transfer
Our vision for better medicine puts clinical operations at the core of our business. We believe that by focusing on clinical operations we deliver exceptional value to our partners.
We see Probiotech as an extension of our partner's team working together towards a common goal of bringing better medicine to the patients.