United States Food and Drug Administration (USFDA) has conducted a Data Integrity Inspection at Veeda CR
Veeda CR is glad to share the successful completion of a USFDA Inspection at Ahmedabad facilities for Healthy volunteer BE studies, by USFDA during Mar 2017.
The Inspection got concluded with – No 483s USFDA Office of Study Integrity and Surveillance, CDER.
The Inspection was announced only a day in advance and Veeda personnel could comply with the data retrieval requests accurately and in a timely manner to support the inspection proceedings.
The Inspectors evaluated the Clinical and Bioanalytical systems along with the Bioanalytical study data as a part of Inspection. The methodology included comprehensive review of Protocol and SOP compliance, entire workflow of the study starting from bioanalytical method validation and project sample analysis related activities like sample receipt, batch acceptance, repeat analysis and incurred sample reanalysis.
Veeda CR team demonstrated the any time audit readiness through this inspection as always. This is a result of rigorous any time audit readiness checks undertaken by Veeda CR teams both at Operational and Quality assurance levels. Such an anytime readiness effort by Team Veeda lead to conclusion of second such Study integrity related USFDA inspection with No 483s with the previous one hosted in Feb-2016. This was possible due to quality conscious personnel driven by a highly supportive, passionate and visionary management of Veeda CR who are sensitive to Quality and Regulatory Compliance.
About Veeda CR

Veeda CR is a Contract Research Organization committed to serve its customers with the Best-in-Class Scientific Expertise and Demonstrated Regulatory Compliance. Veeda CR is a trusted partner of choice for conduct of healthy Volunteer BA/BE studies, Patient based PK End-point and PD-End point studies.

VEEDA CLINICAL RESEARCH PVT. LTD.

Vedant Complex, Beside YMCA club S.G.Highway, Vejalpur,Ahmedabad-380051,Gujarat India

Phone:  +91 79 3001 3000 | Fax:  +91 79 3001 3010 | Email:  info@veedacr.com

Website:  www.veedacr.com