Regulatory Affairs (RA) departments are being held back in their mission-critical role in the project journey according to the 2020 Trends in Regulatory Management report, one of the largest-ever surveys of regulatory professionals across the consumer goods, chemical, and cosmetic industries.
The findings reveal that RA departments are feeling stretched by the implications of heightened consumer demands, new regulatory requirements, and expanding product lines. In addition, the majority of RA teams are stuck using outdated, disparate technology tools like SharePoint, email and spreadsheets to accomplish their work.
So it comes as no surprise that over 90% of RA professionals want modern regulatory management systems with features like dashboards, integrated records, automatic notifications and a single source of truth.
6 Key Findings: RA is Struggling to Stay Afloat Amidst a Perfect Storm
- Regulatory teams are feeling stretched. The survey found the biggest workload drivers were new regulatory requirements (53%) and expanding product lines (49%).
- They are being asked to manage more products, navigate more regulations and do it more transparently. With heightened expectations, it’s no wonder that 50% reported their biggest concern is making a costly or time-consuming mistake.
- RA’s efforts are recognized as vital to an agile organization, with 85% reporting that the registration process is very/extremely important in speed to market. Read our recent blog post “Can we launch this cosmetic formula?” to explore further.
- Given their mission-critical role, it’s all the more startling that the majority of survey respondents report they still rely on disconnected and outdated tools (~ 50% use spreadsheets, email and SharePoint) and processes, which are inefficient and introduce greater risk of costly errors and/or delays.
- RA professionals overwhelmingly (~90%) want a modern regulatory management system providing a single source of truth, dashboards, and notifications that can deliver transparency and efficiency. This finding highlights the disconnect between the disparate systems and processes RA uses today and what they seek. See how DSM is unifying their regulatory documentation across product types.
- As more organizations commit to modernizing their business systems, RA is often left behind, with 4 out of 5 reporting they’d have to go to another department for digitalization budget.
Given this state of affairs, many companies are unnecessarily putting their brand reputation and business growth and at risk by neglecting RA in their digitization efforts. Modernizing regulatory management represents a low cost, low-risk proposition when compared to costly regulatory mistakes, missed product launches and/or M&A activities to address category expansion and new category entry.
Exciting News: More than 200 highly regulated companies are streamlining regulatory operations with Veeva solutions
An increasing number of highly regulated companies are adopting Veeva’s regulatory applications to streamline regulatory information management. More than 200 companies are now using Veeva to modernize their regulatory business operations for faster submission development and better visibility across processes for improved compliance.
"Veeva helps us to overcome challenges in Regulatory and Quality Assurance of BASF’s Crop Protection and Seed & Trait business,” said Rainer Becht-Mattern, Head of IS Business Architecture R&D, Crop Protection, BASF. “Veeva Vault provides a foundation for our digital transformation with great potential within our Agricultural Solution business, but also beyond.”
About the 2020 Regulatory Trends Report
Hanover Research, an independent research firm, surveyed 268 individuals working in the cosmetics, consumer goods, and chemical industries at globally-scaled companies earning at least $500 million in annual revenue. Over 50% of respondents are manager level or above with at least 15 years of work experience, and all participate in some form in managing regulatory compliance at their organization. The top 4 regions that respondent companies service include North America (98%), Europe (52%), Asia (43%) and Latin/South America (40%).