PRESS RELEASE

NPIL's Wellquest CRO Audit by ANVISA, Brazil 

Mumbai November 28, 2003: Wellquest is an independent clinical research division of Nicholas Piramal. Wellquest is a professional, state-of-the-art Contract Research Organisation (CRO) compliant with international regulatory norms of Good Clinical Practices (GCP). It has been accredited by the DCGI for clinical research studies.

Wellquest has been operational for three years. During this period several Indian and international pharmaceutical companies have conducted successful audits. Wellquest has carried out pivotal Bioequivalence (BE) studies for submission to regulatory bodies in UK, Europe, South Africa, Australia and Latin America. 

Wellquest dossiers have been approved by UK-MHRA and Brazil-ANVISA. In fact, the Brazilian regulatory body ANVISA (Agency National for Vigilance Sanitaire) now makes it mandatory that all CROs be pre-approved before any study is conducted with them for Brazilian submission. Wellquest was the first Indian CRO to undergo such a facility audit (from 20th to 24th November) by ANVISA under its new guidelines. 

ANVISA audit was highly successful and would certify Wellquest as an accredited center of ANVISA in India. Wellquest has conducted over 20 studies for different sponsors for registration in Brazil. Another eight studies are currently in various phases of execution. 

Besides ANVISA, eight other international clients/regulatory bodies are currently auditing Wellquest.