Bioavailability & Bioequivalence
Our state-of-the-art infrastructure spread over 12,000 sq. ft. facilitates one stop centre for executing BA/BE studies:
- 42 beds spread over 2 clinical units for simultaneous conduction of multiple studies resulting in quick turnaround time
- Quality control planning to ensure 100% accuracy of critical variables
- QC during process: manual review of critical data fields in CRFs
- All activities and results are checked by a colleague statistician.
- Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers provide high quality data analysis & statistical report writing in accordance with regulatory standards
- Protocol preparation team holds strong experience in conducting clinical studies with medical or pharmacy background designed clinical studies
We offer extensive bio-analytical services in drug development by conducting analysis ranging from evaluation of drugs in samples to biostudies. Our bioanalytical department spread over 2000 sq. ft. which facilitates offering end to end bioanalytical support with team of qualified analysts. We have a successful track record of regulatory inspections /audits by the USFDA, EMA, MHRA, TGA, DCGI, ANSM,BfArM.
Our quality policy is to conduct business through self imposed Professional Ethics and Quality Management Systems. Synapse has more than 300 SOPs to regulate different research activities within the unit.