Regulatory Affairs

Discover more

Who is our
division lead?

MEET MAURIZIO SUPPO

Division dream

FOCUS FOR THE COMING 3-5 YEARS

We want to become

a strong, homogeneous and cohesive team which thrives on our diversities and cross fertilization of professional knowledge and expertise

We want to develop and consolidate

a strong international reputation as one of the top regulatory consultancy experts in life sciences

We aim

to be a top 5 regulatory consulting company in the EU for our industry

Continue to invest in people

by retaining our key top-performers & further grow their professionality by reaching the ideal balance between billable work and professional continuous education
by attracting top-talents from outside

Development of the QbD Group brand

as sponsor & attendee of major industry-related regulatory events

Thought leadership in the regulatory field via

high-value webinars
publication of pertinent articles
being viewed by both National Authorities and Notified Bodies as a “go-to resource” for the life sciences industry

The future

"We see the future as challenging, but equally as a strong opportunity."

What do we actually do?

We are focused to help manufacturers worldwide -not only European manufacturers- on how to comply with all the regulations that are applicable to the healthcare market. And that covers pharma, which is the biggest of the three markets, medical devices and IVDs.

The reason why there are regulations is that from the authority point of view, there is the concern that these products -if they are not performing well- have an impact on the health of all of us as people, as citizens. Therefore, in order to prevent that, the authorities want to make sure that the products comply with specific requirements. That is where we help manufacturers.

Our values

The value of QbD that really stands out more as an indicative factor for what we do is ‘going the extra mile’. Because the regulatory field is pretty complex and not everything is black and white. There is a lot of interpretation. So we really have to put in the extra effort to understand the needs of the customers and address those specific needs, and not just stop at the easy answer.

Regulatory Affairs in QbD

The Regulatory Affairs division is important because -very often- the difficulty to understand and overcome the regulatory requirements is the primary reason for which clients in the healthcare industry come to us. Some of the work can be done by ourselves in the Regulatory Affairs division, but more specialized work is passed to the experts of the Qual-Val, Clinical, Quality and Software divisions. So we act as a conduit that channels work to the other QbD divisions and thus enables QbD to be a one-stop-shop for our clients.

Which part of my job gives me the most energy?

“The synergy in our teamwork is very valuable.”

A few words from some colleagues…

ANNE & JENS

What character traits make you shine in Regulatory Affairs?

In order to work in our division, you need to be very oriented to details. But at the same time you need to have presenting skills in order to present to your customers what’s the best interpretation of what you have read. It's like a dichotomy, because on one side you need to be super technical -super detail oriented- and on the other side you need to be able to convey the message to an audience.

"I have to say that I'm pretty proud. I was honored that the QbD management put me in this role. And I think that there is a lot of opportunity to drive the division forward, because the overall context is favorable. Healthcare is growing and with it the need for compliance. That's why I feel pretty honored to be in this job."

Maurizio Suppo, Division Head Regulatory Affairs