Regulatory Affairs

We at Voxtur offer regulatory consultancy services for clinical trials and BA/BE studies to support the bio pharmaceutical industries for approval of drugs. Our dedicated team has experience in handling inspections of regulatory agencies like USFDA, MHRA, WHO, NPRA, EMEA and ANVISA.

We understand the expectation of regulatory agencies which reflects in the service and this converts to our clients achieving their goals. Our regulatory consultation service include:

• Site monitoring for clinical trials
• nvestigator site audit/Site monitoring for clinical phase of BA/BE studies
• Document audit which include clinical study reports, trial master file and CRFs
• GCP/GCLP compliance site inspection
• Complete data audit for bioequivalence studies (clinical, bio analytical phase and PK phase)
• Archive facility audits
• System audits
• 21 CFR 11 compliance