Bioequivalence studies is a science based regulatory affairs project which includes a combination of studies based on specialization. The main aim is to establish if rate and extent of absorption of the given sample of the drug is comparable with innovators formulation.
Our StrengthsTie Up with well established study centers to carry out BA / BE / Clinical Studies.
We add value byHelping clients carry out BA/BE studies in well established study centers, which are approved from local DCGI and international WHO, EU, US FDA, Geneva, TGA – Australia, Medsafe – New Zealand and Brazil – ANVISA.
BA/BE Studies ConductedConducted more than 200 Studies for Semi Regulated Market like CIS Countries, Russia, Latin America, African countries, Middle East, South East Asia Countries etc.
Conducted over 12 studies for highly regulated market like Europe, TGA-Australia, South Africa, Brazil Anvisa.