Division rebrands as UL Compliance to Performance, a service that goes beyond employee learning to full company compliance, safety, and operational strategy.
Most people likely recognize UL and its iconic mark for its centuries-old practice of safety standards and certification in connection with electric devices and components.
That business has thrived since the company’s birth in 1894 as the Underwriters’ Electrical Bureau, a unit of the National Board of Underwriters, and its identity through the 20th century as Underwriters Laboratories.
But, over the years UL has evolved into a brand with a corporate mission going well beyond electrical safety into “Working for a Safer World,” including pharmaceuticals and medical technologies.
Expansion of Services for Life Sciences
To that end, the former UL EduNeering unit, which had built a software-centered educational system, now officially has embarked on a rebranding campaign as UL Compliance to Performance, an identity which division leadership says better reflects its transformation into a full pharmaceutical and life sciences consulting service. UL acquired EduNeering from Kaplan Inc., an international provider of educational services, in April 2012.
At the time, EduNeering was designed to fully focus on GxP compliance of life science employees through courses and a learning management system that were developed together with the U.S. Food and Drug Administration.
Since that time, the focus gradually has expanded beyond compliance courses and software to working as consultants directly with life science companies, according to Isabelle Noblanc, general manager of UL Compliance to Performance.
At present, most work is done on shorter-term contracts, but there have been discussions on implementing yearly or blanket contracts, she said.
The Key Market Segments
As for market segments, Noblanc said the company serves all segments from large producers to CMOs and CROs, but one segment in particular seems to need more attention than others.
“We serve most of the largest pharma companies in the U.S. and also in Japan, but the large companies are more sophisticated typically,” Noblanc said. “The segment that needs us the most includes the mid-sized companies, those about to commercialize products or have just commercialized products. They typically need more help than the big guys or the smaller companies that aren’t quite there yet,” she said.
The transformation of the division from software to full-service consulting actually began in 2015 when UL embarked on a program across its core business sectors in the U.S., India, Japan, China, and the U.K. to determine the goals and challenges of the life science businesses, and gaps in available solutions that they were encountering.
“What came out of it was that all companies no matter where they’re located in the world were maturing from a focus on compliance to a focus on quality to a focus on performance,” Noblanc said.
They had access to large consulting companies like PwC Consulting and Deloitte Consulting LLP to help them with their high-level business strategy as well as smaller consulting companies that were very technical in nature, but there was a lack of consultancies in the middle to work with them on operational strategy.
“We figured we already had one foot in the people-compliance side of things and we were already moving towards improving the competency of employees, but we were not addressing the process and our technology platform was only on the people side,” she said.
Based on that, the division moved to add on-site advisory personnel to help companies move from compliance through to business performance, Noblanc said, and currently is in the process of changing into a modular, scalable, plug-and-play technology platform and one that can work with outside systems already in place.
An Opportunity for More Growth in India
At the time of the interview with Pharmaceutical Processing, Noblanc had just returned from a conference in India, where production of generics and biosimilars has exploded.
“The whole country pretty much focuses on generics and biosimilars now, and most of the clients in India who had just focused on generics are opening plants for biosimilars now or operating second units that focus on biosimilars,” she said.
“Everyone is talking about the new (Trump) Administration and whether that’s a threat for India, but government officials at the conference said ‘we don’t know, but we probably need to look at it also as on opportunity for India.’”
Government officials told the gathering that with price pressure now placed on drugs in the U.S., and with the heavy concentration of low-cost generics and bisimilars originating in India, the country should be in a good position to help the U.S. reduce prices, according to Noblanc.
The India manufacturers also were advised that in order to meet expected new opportunities in supplying pharmaceutical products to the U.S., they need to focus on a higher level of quality—a concept of “anytime compliance” so they’re not just focusing on when an FDA inspector will come. Instead, they need to stay ready at all times and in all facilities, even when opening a new plant in a remote area.
Expanded Agreement with the FDA
In all countries, Noblanc said that the move for complete traceability and serialization throughout the supply chain poses a huge regulatory challenge for pharmaceutical companies today.
To help meet that challenge, Noblanc said her division concentrates on traceability in the supply chain, while UL’s Supply Chain and Sustainability division helps with the transparency of the products themselves. A third division focuses on counterfeits, including in pharma.
UL Compliance to Performance recently extended its agreement with the U.S. Food and Drug Administration by five years through 2024. The previous agreement signed under the EduNeering banner through 2019 was in place to create and provide training material for FDA investigators along with access to the division’s management system software.
The new extended agreement goes beyond pharmaceutical and medical device training to include similar programs for food and beverage investigators. The division, which now has similar training partnerships with some regulatory groups in India, is working on arrangements with regulators in other countries as well, Noblanc said.
Goals and Strategies in the Five-Year Plan
In 2016, UL Compliance to Performance acquired former partner LearnShare, a small Ohio-based software company that specializes in global talent management and performance measurement.
LearnShare’s non-GxP training business complements UL’s strong position in GxP, she said, adding that her division has plans to add quality and laboratory information management systems over the next year or so.
Over the next five years, Noblanc anticipates the division completing its transformation initiative with a technical system platform that suits current needs and allows for future growth expansion, along with global expansion of the consulting business.
“Today, we’re heavily U.S.-centric because that’s where we came from,” she said. “That’s why we’ve been working on our global expansion for the past three years, but in five years I think we’ll be wherever our clients need us to be.”
A second round of expansion likely would target Germany, Switzerland, France, Italy, and perhaps other countries in the European region, along with Brazil and Australia, she said. The aim is to focus on countries and companies that exhibit high sophistication and standards in compliance and quality.
But such expansion won’t necessarily mean a reliance on additional acquisitions.
“For us, we look at acquisitions to fulfill and execute a strategy,” she said. “If we’re looking at strategic gaps we have today, we always compare acquisitions versus developing in-house versus partnering with someone, so we look at all three.”
This feature story can also be found in the July/August 2017 issue of Pharmaceutical Processing.
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!
