With our long history as a pharmaceutical manufacturer, every project at Medreich receives the highest quality with the greatest efficiency and speed possible. We proudly provide uncompromising performance backed by intellectual distinction, top of the line equipment and state of the art processing.
Medreich provides cGMP manufacturing for Bio Batch products, including tablets & capsules. We are capable of producing batch sizes ranging from a few thousand units to over a million units per batch.
Medreich R&D has a strong team for the design execution and analysis of Bioavailability and Bio equivalenence studies.
The BE team work closely with the Formulation, Analytical and Regulatory teams for the designing and execution of the Bio equivalence studies and compilation of the Dossiers. We also co-ordinate with various National and International Clinical Research Organizations inspected by regulatory agencies like USFDA, UK MHRA, WHO, ANSM, ANVISA with their experts and project management team for the timely execution of the Bio equivalence studies. We are responsible for the complete Bio-pharmaceutics, Clinical Pharmacology and Pharmacokinetics review. Every year we conduct sizeable number of studies. Various types of study designs are adopted depending upon the complexities of the drug product for the conduct of the pilot and pivotal studies. The commonly adopted study designs are Single dose two – way crossover studies, Partial and fully replicated studies and Multiple dose studies.
The team is involving from designing stage till the end of the studies.
- Site selection and the site Audit
- Investigational Protocol design, CRF design and informed consent design.
- Statistical plan, size sample calculation.
- Monitoring and Audit of Clinical and Bio analytical phase of the studies.
- Review of Data statistic analysis and Bio equivalence analysis.
- Compilation and review of the Non-clinical and Clinical section.
Bio equivalence studies are conducted for various oral dosage forms. All the Bio equivalence studies are conducted according to the ICH and as per the pertinent regulatory guidelines and as per the Current Good Clinical Practices and Good Laboratory practices.