Alvogen Inc the US-based generic pharmaceuticals company has made an investment of US$ 5 million to commence its operations in India by setting up a clinical research organization under the name Norwich Clinical Services and an API sourcing office in Bangalore. It will open a dedicated centre for Pharmacovigilance which is viewed as the next area of growth in the clinical research segment.

The CRO will be managed by Alvogen´s subsidariary Norwich Pharmaceuticals. The company will offer a complete range of clinical research capabilities, including phase I-IV trials, bio-analytical studies and pharmacovigilance monitoring. The CRO will employ around 100 people, within its first year of operation. The Groups sourcing office operates under the Alvogen name.

The facility will span 30,000 sq ft and will be commissioned in June this year. The bio analytical lab will have 12 LCMS installed. Norwich Clinical Services has commenced hiring post graduates and doctorates. By the year end, the strength of the team will be between 80-100.

The key personnel heading the operations are from the Bangalore-based Lotus Labs a leading CRO in the country. They include Dr Saral Thangam, former managing director, Lotus Labs and Technical director, Lotus Clinical Research Academy, Sudhir Pai, managing director, Lotus Clinical Research Academy. director and Fjalar Kristjansson.

The key reason for Alvogen to enter India is the vast opportunities in the area of clinical research. The hospital infrastructure, medical- scientific prowess of English speaking professionals, large naïve patient pool and cost advantage are other advantages, said Sudhir Pai, director, Norwich Clinical Services.

"We are confident that the company will succeed because it is manned by a team which has the ability and expertise in the sector," he added.

The CRO will specialize in the management of clinical trials and offer a complete range of clinical research services to Alvogen and third parties. The sourcing office will play a central role in further strengthening Alvogen's relationships with Indian suppliers for raw materials.

"With Pharmacovigilance being a key area of growth, we are looking to begin with assignments offloaded by the parent company in addition to third party contract. We are also gearing up to tap the Indian market opportunities," said Pai.

"This strategic move provides us with valuable CRO capabilities in India, at the same time as it supports our fast growing third party business. Our goal is to build a world-class CRO in India that can enhance our global R&D work. After years of experience with the Indian team in creating and growing Lotus, we look forward to expand our new business in India," said Robert Wessman, executive chairman of Alvogen.