BA/BE Studies
Bio equivalence studies is a science based regulatory affairs project which includes a combination of studies based on specialization. The main aim is to performed to establish if rate and extent of absorption of the given sample of the drug is comparable with innovators formulation.
Our Strengths
- Experienced and Qualified staff in carrying out clinical studies
- Tie Up with well established study centers to carry out Clinical Studies.
We add value by
- Helping clients carry out BA/BE studies in well established study centers, which are approved by US FDA and follow GLP, GCP.
BA/BE Studies Resources
Our Associated Study Center Description
BA/BE Studies Conducted
- Conducted over 50 Studies for Semi Regulated Market like CIS Countries, Russia, Latin America etc.
- Conducted over 10 studies for highly regulated market like Europe & USA.
- Our Center has the following approval
- DCGI, MCCA South Africa, Turkey MOH, Submitted Study to UK MHRA, Conducting study for WHO Pre-Qualification Program.