Regular Operations Automation
 
KNOWLEDGE CENTER

Regulatory Operations Automation

In each and every country marketing authorization is one of the most important tasks centered on regulations and guidelines for reporting and evaluating data on medicinal products' safety, quality and efficacy. Each country has its own system and procedures for marketing authorizations, not only in vocabulary and definitions of medicinal products, but also in different organizational structures and practices of individual regulatory authorities. This represents a serious drawback for efficient local and worldwide licensing of medicinal products.

Automation of such marketing authorization procedures and their adequate software support is a critical factor that can dramatically improve the efficiency of regulatory authorities and interoperation of regulatory systems across the world. A dying blockbuster model, tightening regulations and stringent healthcare authorities, and payers sharply focused on value have made lifecycle management of late-stage products extremely important. But most of the life sciences organizations struggle with maximizing the effectiveness of lifecycle management because of high costs, fragmented technology and processes impacting time to market and increased compliance risks due to limited visibility and collaboration.

Automation can help life sciences companies maximize product value by being compliant at all times with applicable regulations, keeping products in market longer, and entering new markets faster. It leverages deep domain knowledge in end-to-end regulatory affairs to streamline processes, embrace best practices, and standardize, where possible, while customizing to meet the unique requirements of each environment. Analytics experts further extend the power of the solution by combining the readily available regulatory data with other external data sources to provide alerts about potential regulatory, safety, or competitive risks by applying sophisticated predictive analytics.

Automation ensures (i) Transparency of the results of marketing authorization applications, (ii) Sharing of marketing authorization procedures across regulatory authorities, and (iii) Interoperation of such procedures with existing healthcare systems and be reusable across a family of related applications.

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