United States Food and Drug Administration (USFDA) - BioResearch Monitoring Program (BIMO) Conducted 2 Inspections at Veeda CR - Ahmedabad
AHMEDABAD, India, October 27, 2017 /PRNewswire/ --
Veeda Clinical Research is glad to share the successful completion of 2 USFDA Inspections at 2 of its locations at Ahmedabad in Sep-2017. Both the Inspections were Routine Inspections by BIMO (BioResearch Monitoring Program - USFDA) covering Clinical Phase of Healthy Volunteer BE studies.
(Logo: http://mma.prnewswire.com/media/591114/Veeda_Clinical_Research_Pvt_Ltd_Logo.jpg )
The outcome of both the Inspections was - no issues identified in the studies conducted at Veeda facilities, i.e. No 483.
Veeda Clinical Research has faced 18 USFDA Inspections in last 24 months out of which 14 were clinical trial site inspections and 4 were for Healthy volunteer BE studies. Out of 4 Healthy volunteer BE study inspections, 2 were from the Office of Study Integrity and Surveillance and 2 were from BIMO (BioResearch Monitoring Program - USFDA). We are glad to share that 17 out of these 18 USFDA Inspections got concluded with No 483, which demonstrates our commitment levels towards Quality and Regulatory Compliance.
With an enhanced focus on 'Right First Time' approach, Veeda CR looks forward to a brighter future in Clinical Research Arena. These inspections are another testimony to Veeda CR's continuous quality review and improvement measures institutionalized into the work culture, by our visionary and a highly quality conscious Management.
About Veeda CR
Veeda CR is a full service independent 13 year old CRO based in India that conducts clinical research to support clients in their clinical programs. The company provides expert services in PK (pharmacokinetic) and PD (pharmacodynamics) studies in healthy volunteers; conducts patient trials in generic molecules and NCEs (new chemical entity) and undertakes research in Biopharmaceuticals. The company offers a fully integrated package which includes services on Phase I to Phase IV clinical trials in central nervous system, oncology, and other complex therapeutic areas. The company's services also include clinical trial management services comprising patient recruitment and retention, project management, clinical monitoring, drug safety/pharmacovigilance, medical affairs, quality assurance, and regulatory and medical writing to meet global clinical development needs. The company has conducted over 2235 clinical studies for regulatory submission to USFDA, MHRA, EMEA, Health Canada, ANVISA, TGA, WHO, MCC, GCC and China FDA.
Media Contact:
Priyanka Tiwari
[email protected]
+91-7069054041
Share this article