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Integrated Global Regulatory Services: Finding Solutions for Regulatory Affairs

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Bharathi Ramesh,DirectorBe it any industry, consultancies need to find clients and secure contracts to lubricate the flow of essential materials. Delivering comprehensive services in the pharmaceutical space with regard to manufacturing and developing has become a key concern for consultancy service providers. Integrated Global Regulatory Services, IGRS, is a regulatory consultancy service provider to the pharmaceutical and life sciences industry that laid its foundation in the year 2010. The company caters to enterprises with people having insufficient knowledge in the pharmaceutical industry domain.

IGRS is the brainchild of Bharathi Ramesh, Director, who has more than 30 years of experience in the pharmaceutical industry with a clear picture of its needs and requirements. To add value for what learned from the industry, she formed an in-house team and talented people to integrate with the industry where they don't have sufficient people to address the issues and requirements. Working in a retainership model encourages IGRS to address the
compliances in a short period of time. The company bears a small team that could take the responsibility and accountability of the work in a diligent way. IGRS has worked irrespective of the cost factor with industries that cannot escalate the skill set of their talent pool, and has added value to meet the expected goal of the project. Within IGRS, employees are asked to maintain good transparency among each other despite the hierarchy followed, and commendable works are appreciated and encouraged. "The requirement nowadays is not just growing in pharma, but has also come to medical devices and consumer healthcare. The industry should know that their product has to meet compliances when it goes to a particular country. This information may not be available to everybody. We help them in the early product development right through to licensing, to the market and beyond", says Bharathi Ramesh, Director, IGRS.

IGRS has worked irrespective of the cost factor with industries that cannot escalate the skill set of their talent pool, and has added value to meet the expected goal of the project


IGRS has acquired ISO certificates of 9001:2008, afterwards 9001:2015 and has also volunteered for CSR activities by establishing an Ayurvedic unit. Currently, the company exhibits a revenue growth of more than 10 to 12 percent year-on-year with exponential growth reaching 25 percent at times. Having consultancy operations and office situated in India, IGRS has also acquired customers from Spain, Germany, U.K, Israel, and Czech Republic. In India, it has catered to the cities of Delhi, Mumbai, Ahmedabad, Hyderabad, and Chennai. Aligning the industry goals with the best requirements always pose issues with the mismatches between the consultancy and management team. IGRS lists out the complete requirements of the customers and tell them how it will be finalized with-in the timelines. "The biggest challenge is to work together and take it forward to meet the timeline of the management. The company balances working with the management as well as the doer level. We have done ease out of their passages and have been successful in meeting their goals", concludes Bharathi Ramesh, Director, IGRS.