"This is an industry without a growth limit in sight, so we, as a company, need to grow fast with the market."

Gilda D'Incerti

CEO AND FOUNDER, PQE GROUP

July 14, 2021

PQE Group was founded 23 years ago and today it has 26 offices. Could you introduce the company?

I founded PQE on the back of my IT expertise, coupled with my experience in the life sciences industry. This unique background made PQE a pioneer because other consultant companies had an engineering foundation. We started with three people in 1998, and today we have 1,000 people working globally. From the start, we had a global vision, and the standardization and systematization of international regulations since 2000 allowed us to expand and work in unison with many markets.

Having opened new offices in 2020 in the US, India, Belgium and Poland, what is your expansion strategy and what are your main targets?

The life sciences market was evaluated at over US$6 trillion in 2019, an unimaginable figure, while the market share of the biggest pharma companies remains quite small. This is an industry without a growth limit in sight, so we, as a company, need to grow fast with the market. That said, the life sciences industry is moving at two speeds: the US and the Rest of the world. The pandemic showed the strength of the US industrial machine, and the US industry responded much faster compared to Europe.

Our goal is to become a recognized player in the US. China is our second key focus – together with India, the two countries account for 80% of API global production. Though the process of re-shoring or regionalizing production away from China has started, this will take many years. Meanwhile, this will remain a key pharma hub.  

What are your key services?

Revenue-wise, 50% of our business is represented by our data integrity and digital services, naturally the DNA of our company. The rest of our service offer is complemented by qualification and engineering, regulatory affairs, and audits. These business lines change with the trends – at the moment, a very sought-after service stems from the impetus of reshoring (or the localization of production), with many new plants being built in the West. This trend led to increased demand for our engineering and commissioning qualifications, as well as our compliance services. Because most of the industry’s production is currently geared towards vaccines, our regulatory affairs services have been less important since the pandemic. Overall, geopolitical factors strongly impact our business, but we have a flexible structure and our team can shift from one area to another.

What are the main trends in terms of regulatory compliance?

We have noted in the last three to four years the uptake of a “critical thinking” approach: this involves applying risk management thinking to avoid anything considered non-mandatory, superfluous, or a mere formality, to instead concentrate more on the substance, on what is critical and necessary. In a sense, this marks a return to original GXP practices. As consultants, we support this movement because we have experienced in the past the hurdles of duplicated testing and unnecessary paperwork. I believe this common-sense approach comes from a period of crisis whereby (especially) European drug prices declined significantly, hurting margins and resources.

However, there is a thin border between simplifying guidelines and finding shortcuts, particularly at a time when inspections have virtually disappeared in the last 18 months. I should also highlight this is not a legal change – the laws, be it FDA, EMEA or HRA, have stayed the same for many years, but what have changed are the guidelines to interpret these laws.

PQE is leading the Smart Manufacturing Coalition. Can you share your thoughts on the industry’s trend towards greater digitalization and automation?

The industry is gradually adopting robotic solutions that will substitute, sooner or later, most of the end work in the industry. Besides the complete automatization of the production line or warehouse, it is also interesting to see the creation of “BOTs” – to automatize specific operations in admin, training, or creating SOPs. This is an altogether unstoppable and disruptive process that is both beneficial and worrying in the sense that it will displace many workers from their jobs in the next few decades.

You recently launched PQE Academy – an internal training program that gives your employees the possibility to receive funding for a Master degree. Can you speak more about this project and share the company’s core values?

The human resource is the planet’s main resource, and clearly the main resource for a consulting company like ours. My personal mission as an entrepreneur has been to create a workplace and to this day I measure our success based on the headcount and the diversity we can forge within our teams: if people of different cultures can work together in the same place, this is a great success for the community.

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