Regulatory Affairs & Operations Automation
For all companies, In each and every country marketing authorization in primary or multiple companies is one of the most important milestones and that is centered on regulations/guidelines for reporting and evaluating data on medicinal products' safety, quality and efficacy. Each country has its own regulatory pathway 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 leads to increased load of Regulatory work and half of that is manual repetitive.
Automation of such Regulatory procedures can dramatically improve the efficiency and productivity of manufacturers. A shrinking blockbuster model, tightening regulations and stringent healthcare authorities, with 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. Offshoring has it’s limitations with Oversight burden and attrition burn.
Automation can help life sciences companies maximize product value by being compliant at all times with applicable regulations, keeping products in the 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 can be applied to:
- Regulatory Intelligence areas
- Reg Ops (auto-publishing, auto-QC checks, Compliance reviews, and more)
- Labeling (CCDS to local checks, Manual QC elimination, Compliance checks, and more)
- Health/Regulatory Authorities responses automation
Talk to us on how to introduce Automation into your processes.