India-based CRO completes second successful audit

24-Oct-2018 - Last updated on 24-Oct-2018 at 17:24 GMT

(Image: Getty/BernardaSv)

The India-based CRO Veeda Clinical Research has completed a second audit by the Malaysia Regulatory Agency, following 18 US FDA inspections over the past two years.

The company’s clinical facilities in Shivalik, Ahmedabad, and bioanalytical facilities in Insignia, Ahmedabad, have successfully completed a second audit by Malaysian Regulatory Agency (NPRA).

The audit was completed without any major or critical observations, according to the India-based contract research organization (CRO).

The routine inspection was to verify compliance and good clinical practices (GCP).

Veeda has successfully completed 50 regulatory audits in the past 13 years, including 18 US Food and Drug Administration (FDA) inspections in last 24 months.

The company conducts PK (pharmacokinetic) and PD (pharmacodynamics) studies in healthy volunteers, patient trials in generic molecules and NCEs (new chemical entity), as well as biopharmaceutical research.

Veeda has not responded to a request for comment.

According to the Australian-headquartered CRO, George Clinical – which also operate in India – regulatory changes have brought clinical research in India “back on track,” with the market expected to grow at a CAGR of approximately 12%.

According to the CRO, 2017 to 2018 saw a “significant rise” in the number of clinical trial approvals, from 178 in 2017 compared to 84 in 2016.

Additionally, the average time for clinical trial application approval decreased from about 6 to 7 months in 2016 to an average of 4 months in 2017 to 2018.