The contract research arm of Nicholas Piramal, Wellquest, has received approval from Agency National for Vigilance Sanitaire (ANVISA) of Brazil. The Brazilian drug regulatory body, ANVISA, has now made it mandatory that all CROs be pre-approved before any study is conducted with them for drug registration in Brazil. The Drug Controller General of India (DCGI) only recently accredited this CRO for clinical research studies.
According to Swati Piramal, director, Strategic Alliances and Communication, NPIL, Wellquest was the first Indian CRO to undergo a facility audit by ANVISA under its new guidelines. An independent clinical research division of NPIL, Wellquest is compliant with international regulatory norms of Good Clinical Practices (GCP), she added.
Operational for the last three years, this CRO is learnt to have completed several Indian and international projects and its has also carried out pivotal Bioequivalence (BE) studies for submission to regulatory bodies in UK, Europe, South Africa, Australia and Latin America. Apart from the ANVISA approval, the Wellquest dossiers have been approved by UK-MHRA as well. The sources informed that eight other international clients/regulatory bodies are currently auditing Wellquest.
With the successful audit at the center, the Brazilian regulatory body has certified Wellquest as an accredited center of ANVISA in India. So far, the CRO has conducted over 20 studies for different sponsors for registration in Brazil. Another eight studies are currently in various phases of execution, the sources from the company said.