Mastering Regulatory Compliance Anywhere
“As governments around the world strive to ensure patient safety and strengthen healthcare systems, they enact new laws and regulations that affect pharmaceutical companies … Pharmaceutical companies must invest more time and resources in complying with new regulations, which may delay the launch of new drugs and increase costs.”[1]
Keeping on top of global regulatory requirements is a costly challenge -- the US Food and Drug Administration alone has implemented more than 2,000 new or modified regulations since 1998.[2]
Typically, managing the myriad of global compliance obligations and deadlines has meant managing regionally fragmented and manual processes that introduce errors, slow time to market, and increase drug development and filing costs. As pharmaceutical companies further expand their global markets (and global compliance requirements,) profitability will depend on controlling the cost of compliance with solutions that are right the first time, lower risk, and enable better visibility into regulatory intelligence.
A global healthcare company headquartered in the US and already supplying 90+ products to more than 135 countries sought to consolidate and organize regulatory intelligence and requirements data to reduce costs and enable growth. Virtua Pharma Technology helped them implement a Regulatory Requirements Database (RRD): a globally accessible, SaaS-based solution that includes comprehensive requirements for regulatory activities across more than 250 countries. This system enables local affiliate clinical research associates (CRAs) and headquarters subject matter experts to review and maintain requirements for post-approval changes, renewal filings, and general market and testing requirements, with dashboards for regional experts to facilitate timely review processes. Compliance tracking enables the business to stay up-to-date with changes, manage risks, and create transparency in their compliance efforts.
Success of the project hinged on extensive business analysis, gathering and analyzing requirements across global CMC and country regulatory affair functions. Virtua Pharma Technology then worked closely with the vendor (Graphite GTC) to develop a new solution built on a single, scalable platform and simplify their distributed legacy architecture into one application. Integrating over 400 regulatory change updates, the team conducted rigorous testing to ensure the system met the needs of user roles that spanned functions, countries, and categories, then followed up with training that empowered users to be successful on Day 1 and beyond.
[Virtua Pharma Technology’s (VPT’s)] dedication, expertise, and attention to detail have been invaluable.
VPT’s exemplary efforts continues [sic] into post implementation phase. Your dedication to resolving issues promptly, providing user training, and ensuring a smooth transition has been commendable. Thanks to your hard work, our users are adapting seamlessly to the new system, and any hiccups have been swiftly addressed.
VPT has become an essential part of our team and contributing to our success. We look forward to continued partnership and collaboration in the future.
(Director - Regulatory Innovation, Information & Digital Management)
As the system grows, Virtua Pharma Technology continues to provide training and support for new users while also looking for new ways to help the client leverage the database for the growth of the business.
[1] Impact of Regulatory Changes on Pharma, Laboratorios Rubió
[2] "Disruptive Trends in Pharma Regulation", PwC, Pharmaboardroom.com, June 2018