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Avantis Regtech sees compliance as a critical component in pharma sector to improve its performance

Nandita Vijay, Bengaluru
Tuesday, August 20, 2019, 08:00 Hrs  [IST]

Avantis Regtech, a SAAS solution provider, sees that pharma compliance is critical across drug manufacture to marketing. This is because compliance requirements reduces operational, reputational and financial risks.

Regulatory compliance is top on the agenda as Indian firms are looking to spend a higher proportion on capex for upgrading infrastructure for regulatory compliance over the next decade. Our web and mobile platforms, enable a transparent, accountable and efficient risk and compliance management.

Indian businesses are finding it increasingly challenging to cope with the increased regulatory compliance burden. The pharmaceutical sector is particularly hard hit. Our clients in pharma sector have reported significant improvement in the ease with which regulatory compliance is now being met as our web and mobile based platforms, enable a transparent, accountable, efficient real-time compliance management system, said Rishi Agrawal, co-founder and CEO, Avantis RegTech.

There is an inevitable need to use technology to simplify compliance management. Even as Indian pharma is ready to take on the world, there are strong headwinds in the form of increased compliance.

Group Pharma is a company with almost 40 years’ experience and expertise in manufacturing dental and oral care pharma products. Established in 1980, the company operates from 2 facilities in 2 states and 2 offices, with more than 800 employees. In addition to the complex Indian statutory compliance environment, the company is also subject to other global inspections from regulatory authorities of different countries as it exports to over 40 countries. The company was following the traditional model of Control and Comply 1.0 where the processes were ad-hoc, people dependent and paper-based.

Avantis, a TeamLease company during its process having the Group Pharma compliance enabled, found spreadsheets and emails were used to manage compliance. Moving to Control and Comply 2.0 has meant a transition to a digital, process-based and predictable model of compliance management for Group Pharma, said Agrawal.

The automated digital compliance management system, AVACOM, set up a comprehensive workflow for tracking, reviewing and approving various activities. Since its implementation Group Pharma has reported a significant maturity in their organisational compliance programme. They have seen over 50 per cent reduction in missed compliances. The Compliance Officer now has access to the real time status of over 1,700 compliances without spending any non-productive time in follow ups. The assurance provided to the board has become more transparent and credible. There is a tangible reduction in their penalties and interest expenses arising out of delays. The company is now on top of all the legal and regulatory changes within 24 hours of the release of the notification.

With increasing number of compliances it became necessary to have a digital resource that helps senior management track them and be made aware so that we could take actions in time. With the help of Avantis today we track 1717 internal and external compliances with ease. It is a true example how with limited cost technology can help SME’s, aid Sunil Attavar, managing director, Group Pharma.


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