Bioavailability / Bioequivalence / Clinical Trial Studies (BA / BE / CTR)
We also have active association with approved study centers with state of art facilities to perform BA/BE studies (single dose, multiple dose, 2-way, 3-way, replicate design & dose proportionality studies, immediate and modified release, various dosage forms of known molecules) as well as Phase I, II, & III clinical studies.

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 Strengths

Tie Up with well established study centers to carry out BA / BE / Clinical Studies.

We add value by

Helping 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 Conducted

Conducted 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.

Format And Guideline

As per country specific guideline.


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  enquiry@labeladossier.com