Incorporating Software in Combination with Medical Devices Hardware
Published Dec 04, 2023
Published 22nd August 2023
DLRC Group are thrilled to congratulate Wafa Bouaziz on her well-deserved appointment as Managing Director at Orphix Consulting GmbH!
We sat down with Wafa, to gain insight into her professional journey, discover the pivotal events that fuelled her passion for science, the invaluable lessons she’s learned, and her vision for the future at Orphix.
“In addition to being a regulatory affairs leader, I am a biologist by background. I enjoyed completing my PhD in molecular and cellular biology studying cell signalling and unravelling the molecular mechanisms underlying it.
I have always been passionate about science, and I grew up in a family for whom dedicating a career to improving patients’ health and wellbeing is a natural path.
By choosing a career in the pharmaceutical regulatory industry, I am committed to helping promising products reach the patients that need them most. This is why in 2017, I joined Orphix Consulting GmbH where I accompany several pharmaceutical companies through their drug development journey.”
“Across the multiple projects I have worked on, I learned how to navigate complex regulatory topics to ensure compliance – particularly in areas of high unmet medical need where very limited therapeutic options exist.
When supporting the development of orphan drugs, I quickly learned that the answer is not always in the guidelines and the right regulatory pathway can only be found through engaging interactions with the relevant regulatory authorities.
In fact, in those areas where limited guidance exists, it is key to set a strategy that is fit-for-purpose, think outside of the box and involve the right stakeholders along the way. This has taught me that being a good communicator and a flexible thinker are valuable skills for a leader in regulatory affairs consulting.”
“Orphix Consulting GmbH is a regulatory affairs boutique that was founded in 2002. It has a long-standing history supporting pharmaceutical companies globally to achieve their regulatory goals in Europe and the US.
I believe that what makes Orphix Consulting GmbH special is that our consultants are truly passionate professionals that are keen on providing excellent services to our clients. We take client satisfaction and feedback very seriously and we make sure that we do everything we can to positively contribute to their programs.
Some of our clients have been working with us for more than 10 years, others have ensured they contract Orphix whenever they change companies. To all our clients, I would like to say I am extremely grateful for your trust, there is no better reward than your continuous partnership.”
“In consulting, people are at the heart of the business, they are the key to our success.
Being a small team in Germany, I think that the only way we can achieve success is by working together in a respectful, honest, and non-competitive environment.
I trust that our core values namely quality, innovation, integrity, collaboration, respect, and flexibility are what fosters the positive and productive work culture within Orphix. They serve as a strong compass particularly in challenging times.”
“In my interactions with Orphix clients, the reason they chose to work with us is our flexible, high quality and tailored service. One of my main objectives is to ensure the same excellent quality service for our clients while Orphix pursues sustainable growth.
I trust that within the DLRC group, Orphix has a great opportunity to achieve this goal. Indeed, by being part of the DLRC group, Orphix has access to more resources and infrastructure that will ensure a seamless and efficient workstream across the organisation. We also have a fantastic opportunity to strengthen our regulatory affairs offering as we can count on more than 100 regulatory colleagues across our UK and US offices. With this larger team of experts, I believe our German office is better equipped to continue advancing global patient healthcare through regulatory excellence.”
“After I took over the management of Orphix in December 2018, I was keen on decorating my new office and personalise it. So, I bought a small plant in a small pot that said, “.” 5 years later, the plant definitely out-grew the pot!
This is my advice: keep calm, dream big but work hard, your efforts will pay off.”
Wafa is integral to how Orphix Consulting operates. Her extensive knowledge, expertise, and unwavering drive are the cornerstones of the company’s success. Clients trust and respect her not only for her deep understanding of regulatory affairs but also for her commitment to their goals.
It’s no surprise that some clients have been working with Orphix for over a decade, a testament to the enduring relationships Wafa and her team build and the exceptional results they consistently deliver.
Wafa’s leadership shines brightly, and we have no doubt that her vision and dedication will continue to steer Orphix Consulting towards even greater heights of achievement as part of the DLRC Group.