MetricStream, the global regulatory compliance solutions major opened its account in the lifesciences space in India bagging the Aurobindo Pharma order.
The integrated MetricStream Enterprise compliance management software is being deployed to manage the audit of product and processes of Aurobindo Pharma's regulatory requirements.
With this order, MetricStream has now chalked out an aggressive strategy to tap more business from the Indian lifesciences space where regulatory requirements are crucial for survival.
The company's patented software, Metric Stream Enterprise Compliance Management, supports multiple regulatory requirements. Its portal 'Compliance Online' is a leading website for regulatory compliance where scores of potential users worldwide log on to know what they need to be compliant. ``The two offerings distinguish us from any solutions provider in the space. We are in discussions with Indian lifesciences' companies which are convinced about our expertise and keen to invest in the right kind of technologies with us. The demand for regulatory compliance in India is only catching up now. We have inked two strategic pacts with TCS and NASDAQ whose association with Indian lifesciences companies can help us increase our customer reach.'' Gunjan Sinha, executive chairman, MetricStream Inc. told Pharmabiz.
As part of the strategy, the company organized a series of seminars at Mumbai, New Delhi and Bangalore which generated favourable response, stated Shankar Bhaskaran, director, global marketing, MetricStream.
The key benefit of MetricStream compliance expertise is that large, medium and small companies can get their drugs and devices to market faster without incurring high costs in regulatory delays.
Regulatory compliance is a `top of the mind' issue for companies because they want to deal with quality and compliance systematically and effectively. The trend is that companies are looking to tackle the problem with a solution that deals not with one regulation but all of it using a single system and this plays into our strength,'' the MetricStream chief explained.
India is recognized as a resourceful outsourcing hub for lifesciences' activities and the key differentiator will be quality compliance more than cost advantage. Export-oriented companies also need compliance to enter the global supply chain as they would be subject to multiple regulations.
If companies take on the onus of handling them on their own, it could be error prone, risky and expensive and if there is a miss, the costs of penalties are huge. For example, Merck lost almost $20-30 million dollars for the Vioxx case and Guidant had a $100 million fine. This has not happened to Indian companies as yet. None of the Indian companies can afford that kind of a jolt, informed Sinha.
MetricStream Inc. customer list includes companies from sectors like pharmaceuticals, medical devices, automotive, food, energy and financial services. Companies like Pfizer, Tyco Healthcare and Philips Medical Systems have opted for MetricStream to manage their quality processes, regulatory and industry-mandated compliance and corporate governance initiatives.