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Our team has expertise in auditing multiple sites, BA/BE facilities across India as well as Audit of IRB/IEC operations & documentation for compliance with Protection of Human Subjects & IRB regulations (21 CFR 50 & 56).
This includes Audit of investigative site operations evaluating adequacy of documentation, adherence
This includes audits of facilities, studies and reports, Assessment of laboratories for compliance with
Systems audits of both pre- and post-marketing pharmacovigilance activities