India is popular as one of the largest producers of pharmaceuticals and for exporting pharmaceutical products across the globe. There are more than eight thousand licensed drug manufacturers in India that require pharmacovigilance practice to be implemented and followed. Also, India is the hub for the rest of the world in Pharmacovigilance services like systems development, system services and case processing. Many pharma companies and CROs based in US, European Union, UK, and Japan either have their own team in India or works with IT companies based out of India.
Pinnaxis works in the area of Pharmacovigilance Business Consulting, System Services, and Regulatory based solutions. With in-depth knowledge of regulatory needs and drug safety systems, Pinnaxis’ team works closely with business stakeholders resolving their key business problems. It keeps a close eye on upcoming regulatory requirements and provides on-time solutions to its customers.
Clients in the pharmaceutical space have several expectations from vendors including their demands on domain and systems expertise with in-depth knowledge and experience in dealing with varied business problems. Clients here also look for strategic planning of their current and future business needs. Following the nature of demands
and requirements, Pinnaxis integrates, merge or extract safety data whenever acquisitions, mergers, or divestments happen. The company with its combined experience of Pharmacovigilance business and systems helps its customers with quick wins and strategic solutions. It has successfully delivered multiple projects related to data extract, data migration between systems and has developed a strong base in this area of safety system services. Pinnaxis helps Pharma companies to meet regulatory and compliance requirements related to safety systems.
By providing on-time solutions, Pinnaxis ensures seamless integration of customer’s safety systems and available during critical times and supporting in pre-audit and post-audit activities. Pinnaxis is equipped with the latest technologies and leverages its best practices, pre-defined processes, methodologies, knowledge base, accelerators, and tools for safety systems implementation, upgrades, data migrations, analytics, validation, and managed services. Started about four years back with only five members; the company has successfully added more than forty strong Pharmacovigilance professionals. Since the start, it has successfully delivered around 30+ projects in the area of Pharmacovigilance across multiple customers.
Pinnaxis’ team works closely with business stakeholders resolving their key business problems
Pinnaxis’ management believes that the market will significantly grow in the next few years. People all over the world are more aware of Clinical Trials and Pharmacovigilance especially due to the COVID-19 pandemic in this century. This awareness around drugs side effects and its reporting to Doctors, Pharmacists, and pharmaceutical companies is expected to even grow further in the next few years. Reporting a side-effect helps Pharma companies and Drug Authorities (like FDA, EMA, PMDA) to keep a close eye on the overall result of the drug/device/vaccine in the market. These results help companies to take corrective actions and saves human life.
However, the pharmaceutical industry is witnessing growth through companies shifting from on-premises to cloud-based drug safety systems and automation of adverse event intake, processing, and submission. Electronic reporting with the latest E2B guidelines has also been a reason for consolidation of safety data with other systems. Amidst these transformations, Pinnaxis is all set to continue providing business consulting, safety system services, and regulatory-based solutions to its existing and new customers. It is also planning to expand its wings into related business areas of its current business offerings.
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