ProductLife Group – Partner for Regulatory Compliance

Paris-headquartered ProductLife Group, a provider of regulatory compliance services for the safe and effective use of medical solutions, follows an impressive growth strategy.

ProductLife Group (PLG) is a life sciences consulting business that offers outsourced services in the areas of regulatory affairs, quality and compliance, vigilance, and medical information. Its expertise spans oversight of both established products and innovative therapeutics and diagnostics.

Established in 1993, PLG has supported a range of clients throughout the life sciences product life cycle, combining local expertise with global reach and spanning more than 150 countries. The company is based in France but operates a number of offices throughout Europe and the United States while planning to further expand its global reach.

The Strategy of Growth

The company has gone through a period of rapid expansion over the last few years, following a change in ownership in 2019.

With this change, the company got not only a new owner but also a new CEO, Mr Xavier Duburcq, who defined a new company strategy, significantly changing the direction of the business, with a strong focus on organic growth and growth from acquisitions.

That strategy has been successfully followed – since 2019, PLG has grown organically by 15–20% per year and each year completed two to three acquisitions. “At first, we focused on adding specific complementary skills to the field we operate in, such as safety and vigilance related to drug development. Now we are strengthening our geographical footprint together with further boosting our skill set,” Mr Duburcq explains.

PLG’s latest acquisition is an example of that vision. In June, the company was joined by Denmark-headquartered Pharma IT, a leading provider of technology and deregulatory compliance solutions for the life sciences industry, specialising in quality and compliance, management consulting, drug development and, specifically, information technology.

“IT competence is becoming even more crucial, as regulations are increasingly based on data management, and both the European Union as well as the FDA are implementing new portals for automated drug data input. The addition of Pharma IT will reinforce our existing quality management and compliance offering with expertise in the field of IT systems implementation, validation and compliance, as well as strengthen our presence in the Nordic region.”

Wide Range of Services

PLG’s clients come from the pharmaceutical, med-tech and biotech industries. “Our services cover the full product cycle from start-up funding and product development to preparations for a medical device or drug approval. Our support is mainly about quality and compliance with regulations, and we also cover all aspects of product vigilance and provide consulting services for market access,” says Mr Duburcq.

“Today, larger companies tend to fully outsource their regulatory and compliance services. That means that for some large clients we manage all the drugs, regulatory and compliance activities.”

He points out that demand has increased for support with the IDMP (Identification of Medicinal Products) process. IDMP is a suite of five standards developed within the International Organization for Standardization (ISO) to facilitate the unique identification of medicinal products in the context of pharmacovigilance and the safety of medications throughout the world.

“The standards have a lot of different components. We help our clients to manage those requirements, organising the quality and data management systems and processes. If required, we help them to find the right software solution, and to integrate the software into their systems.”

Energised to Grow

Reflecting on the latest developments, Mr Duburcq admits that managing steep business growth has been a challenge, but one that has been handled well: as a result of the latest acquisition, the company today employs some 1000 people across its locations – a sharp increase against 2019 when the headcount was under 200.

“You can imagine that such an increase means a permanent change inside the company. We also try to retain the dynamic, entrepreneurial spirit of a small company, so when we recruit new people, they need to adapt to that mindset.”

Most of PLG’s staff are specialists in different fields of medicine and pharmaceuticals, but increasingly also include IT engineers. Attracting the best talent is not easy, says Mr Duburcq, as PLG competes for the right human resources with similar players in the market.

Under the new CEO, the company has fully reshaped the experience of being an employee and has adapted its internal and external communications with the creation of a Social Ambassadors network, Employee Boosters, a Shadow Board & a CSR Committee.

“As part of our strategic plan called ‘Energised’, we want our people to become engaged in certain aspects of company strategy formation. For example, our Shadow Board, made up of elected employees, often young and dynamic, are asked to present their views and to propose projects aimed at company transformation,” says Mr Duburcq, adding that the management is in the process of implementing some of the proposals, including the one of how best to manage new acquisitions.

Increasing the Business

And new acquisitions are certainly in the pipeline – by 2025, PLG is set to reach 2,000 employees as well as increase its presence outside its key markets of Europe and the US, says Mr Duburcq.

“We would like to start focusing on the APAC region next year, with plans to develop the business in the US and Canada. We already have some Chinese and Indian clients, but at the moment we manage them from Europe. As the Asia Pacific region today probably represents a third of the pharmaceutical market, it is an obvious destination for us.”

However, reinforcing activities in Europe and the US is also on the agenda. The company has just become an exclusive partner for EIT Health, the entity in charge of Health Innovative projects in Europe, for the life sciences sector.

“We will provide support for start-ups within the EIT Health’s Venture Centre of Excellence (VCoE). It is an important programme, screening and supporting hundreds of start-ups in Europe focused on new drugs and new solutions, most of whom will need support with their regulatory strategy and market access. PLG will provide that support.”

“I’m happy to announce that PLG has just achieved another step in its transformation roadmap with the acquisition of Zwiers Regulatory Consultancy (ZRC) – a consulting company with offices in Amsterdam and Oss, the Netherlands” Duburcq disclosed.

ZRC offers product development services in the EU, the US, and other territories, covering strategic, scientific, and regulatory support, ensuring regulatory compliance throughout the product life cycle.

The ZRC acquisition will expand PLG’s footprint into the dynamic Dutch life science ecosystem and provide physical proximity to the European Medicines Agency (EMA).

And Duburcq concludes: “This comes as an answer to one of our key objectives for 2022, as expressed in our strategic roadmap EnergiZe 2025, which is to reinforce our ability to support our clients during the development phase.”

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