Management of Bioavailability/Bioequivalence (BA/BE) Studies
- Site Initiation Visits
- On-Site Monitoring Visits
- Site Closure Visits
- Remote Monitoring
- Technical discussion
- Timely and extensive update to clients about the study progress
- Bio-analytical Monitoring
- Scientific document writing (protocol, Consent forms, Case report forms, clinical study report (clinical phase, bio-analytical phase, PK and Statistical phase of the report)
- Regulatory Affairs (DCGI submission, BE NOC and T- License)
RS Serve has monitored more than 70 bioequivalence projects for US FDA and EU submissions.
Extensive experience in qualification of BA/BE centers.
System/Facility Audit of BA/BE Centers:
RS Serve has an experience of auditing more than 10 BA/BE CRO’s in India for number of times.
Other services include: