Norwich Clinical Services, part of the US-based Alvogen Inc, has now successfully cleared the US FDA audit for pharmacovigilance at one of its leading customers' premises abroad.

The US FDA team conducted a surprise inspection of the premises of Norwich’s customer to ascertain the practices it maintained in pharmacovigilance and drug safety. The audit which spanned for four days got the Bangalore-based Norwich to provide every detail of its good pharmacovigilance and management practices that it maintained during a pharmacovigilance reporting process to the US FDA inspectorate team.

Norwich was the US company’s sole pharmacovigilance data provider based out of India. Its team of qualified clinicians offered its expertise to fulfil the audit criteria. This eventually led US FDA to certify Norwich as a competent clinical service provider giving the company an edge in the space. “Every time, we successfully come out of an audit, it is a validation of our capability and adherence to good practices,” Dr Saral Thangam, managing director, Norwich Clinical Services told Pharmabiz during an interaction.

The company which kicked off operations last year out of its state-of-the-art 30,000 sq. ft facility in Bangalore has armed its expertise in the area of pharmacovigilance. Currently, Norwich is carrying out adverse drug reaction studies for 60 drugs  for the European Medicine Agency (EMA) and 10 products with the US FDA, stated Dr Thangam.

For pharmacovigilance, it has a dedicated software 'Oracle AERS' which is a standard software for adverse drug experience reporting and post marketing surveillance.

In order to ensure its total capability in the field, the company has a 24/7 call centre manned by experts to triage adverse drug reaction reported out of hospitals and medical centres globally. The qualified clinicians assess the seriousness as per the label of the drug. There is also Medical Narrative Writing section which collates the data of the drugs and provides the details of the expected ADRs and precautions that need to be taken. The data is transmitted electronically through gateways to the regulatory authorities like US FDA or EMA who acknowledge the information.

“We also carry out regular signal detection program and risk evaluation to gauge safety of the drug products on patients. To begin with we collect every bit of information on the drug from available sources including world wide literature and large databases such as the FDA and WHO data base in order to detect and interpret potential signals,” stated Dr Thangam.

The company also has a team of experts in information technology, quality assurance and regulatory affairs to support the pharmacovigilance programme.

“With pharmacovigilance being the future for clinical research sector and India being sought-after for backend services, we are in dialogue with several international majors and Indian pharma companies to grow our business in the space,” stated Sudhir Pai, director, Norwich Clinical Services.

Norwich has a total strength of 60 personnel of which 12 are part of the pharmacovigilance team. Efforts are on to augment its manpower to 90 by the end of the year, she said.