You can choose Indivirtus as the preferred partner to execute Bio equivalence studies of different formulations and be assured of quality, speed and economy. Our BA-BE centre is approved by USFDA/MHRA/EU/PICS/GCC.
We provide proof of concept to global submissions in an ethical, efficient and regulatory compliant manner.
Indivirtus offers specialized solutions in pharmacokinetic and statistical analysis.
Regulatory support including e-CTD compliant dossier submissions and resolving regulatory queries.
Our team is competent in handling different analytical challenges including pro-drug analysis, parent–metabolites simultaneous assays, chiral analysis, elemental analysis, hormones and endogenous substances.
State-of-the-art Bioequivalence Facility with well-equipped pathology laboratory.
Healthy adult male and female volunteers including post-menopausal women.
More than 200 methods developed and validated from various biological matrices like blood, plasma, serum etc.
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