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Núria Romero | Asphalion

The Biotech industry is evolving at a rapid pace. As a result, Life Science consultants are increasingly in demand for SMBs to access specialist skills and offer reliability in the process. Consulting experts help organizations save precious time and money while building a reliable team of go-to experts under one roof. Life Science consultants and experts also help with the development of business strategies and R&D activities required to develop and launch a successful product in the market.

Companies catering to the pharmaceutical industry have to undergo a rigorous regulatory process to bring a drug to the market—the meticulous research goes into every product, involving several skills from data analysis and statistics to drug development strategies and scientific writing.

The art of giving advice is central to decision-making and often seen as passive consumption of wisdom. That’s precisely the role Asphalion plays in helping the life science industry develop high-quality evidence in order to generate ideas while evolving the healthcare sector.

The Managing Director of Asphalion Núria Romero envisions to be the global reference and driving force in the healthcare industry. Under her leadership—the organization offers a wide range of services—from drug development strategies and scientific writing to medicinal product management outsourcing. In an interview with Insights Care, Núria talks about how the organization provides a one-stop-shop to its clients in the process of drug development.

Delve into her interview to get more insights on Asphalion.

Núria, please tell us about Asphalion in detail.

Asphalion is a Regulatory and Scientific Consulting in Life Sciences founded in 2000, with several offices in Europe and that currently counts with an international team of more than 15 different nationalities.

During all these years at Asphalion we have gained a strong track record in projects involving Medical Writing, Pharmacovigilance, CMC, Regulatory Procedures, eSubmissions, Data Management, and Medical Devices.

We offer a full range of services in all drug development stages that span from pre-clinical and clinical to commercialisation and post-market. We have strong expertise in different types of products, including high complex ones such as Biologics and ATMPs.

This expertise has also grown in terms of geographic scope. So far, we have 1,000 yearly ongoing projects and work for 500 clients from over 50 countries, and the number of markets where we operate keeps continuously increasing. Our experts have built strong personal relationships with regulatory agencies, associations, and key opinion leaders, particularly in Europe, the UK, and North America.

Our global focus and our team’s seniority allow us to implement the right solutions for each client, tailored specifically to their requirements, which allows us to often exceed our clients’ expectations.

Please give us a brief overview of your journey in the healthcare niche, highlighting the USPs of Asphalion.

What makes Asphalion stand out is that we offer complete customer solutions: we are a one-stop-shop covering a full range of scientific and regulatory services in all drug development stages.

Our team is devoted to providing expertise, which is rooted in seniority and engagement; quality, as we are used to delivering results in complex situations, and we do have a high satisfaction rate from our clients; commitment, as we have a passionate and qualified team, willing and dedicated to every project and always up to date to latest standards; and flexibility, as we are constantly adapting to different requirements, and we are used to working with tight schedules.

What are the core values upon which Asphalion is built? What is its mission and vision?

We want to be the preferred partner when it comes to scientific and regulatory affairs outsourcing: our quality and expertise are our core strengths and allow us to adapt ourselves to any request.

The values of our organization are built upon our passion, flexibility, commitment, quality, and companionship. Our team´s mission is our passion: Working together with our clients in order to generate ideas and implement solutions that contribute to improving health in all our lives.

As for the vision, we dream about being a global reference and driving force in the evolution of the healthcare sector, offering the best environment for the individual and collective growth of our team and clients.

What is your opinion on the necessity for the healthcare industry to leverage the emerging trends of technology concerning fulfilling your client’s requirements in the healthcare industry?

Through our technology partners, we co-create solutions that bring added value from the point of view of digitalization and innovation, understanding that there is a need to find a combined effect between scientific and healthcare knowledge and technological and digital knowledge.

For instance, Data Management and the tools that support it reflect the growing importance of automated services when dealing with the regulations. It is key to collect good quality information designed to improve data quality, and that allows companies, besides complying with the corresponding laws, to develop strategies and projects.

Above all, it is necessary to have a skilled team to carry out this journey and a corporate mindset of the whole company focused on how to integrate technology in all solutions we offer to our clients, as well as to be continuously in the search for innovation. Our clients benefit from our team´s knowledge and global focus. Still, they also benefit from our use of sophisticated project management tools that allow us to efficiently coordinate even the most complex international projects.

What was your inspiration and commitment behind developing innovative healthcare products to improve people’s lives?

Bringing our knowledge in the regulatory field to any project and, as a result, making it possible for innovative solutions to reach patients sooner and better. These are not empty words: this is the purpose of our work, and we are very fortunate to be able to see it every day while solving our clients’ challenges.

One of our main recent successes is our contribution to the development of more than 20 projects in the fight against COVID-19, which included: Regulatory support for the development of two vaccines against COVID-19; performance of pharmacovigilance activities for a COVID-19 vaccine; Regulatory advice for a medical device’s software for COVID-19 monitoring; Regulatory support for the preparation of Investigator’s Brochure (IB) and IMPD for COVID-19 treatment and participation in the EU-funded Horizon COVID-19 project of ICFO (VASCOVID). We are proud to have collaborated on these projects, but prouder even of the high level of commitment and energy shown by Asphalion’s team.

As an established industry leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the healthcare industry?

I would tell them to get started as soon as possible! Learning by doing is key to having full competence and understanding of processes, being proactive, seeking out mentors who can orientate you, and, above all, being honest: honesty and integrity are the hallmarks of who we are and what we do.

What are your future goals, and how do you envision further strengthening the stronghold of Asphalion in the healthcare sector?

Thanks to the seniority of our team and its continued training, we have a clear vision of what the regulatory landscape will look like in the short and long term, so we can prepare ourselves and advise our clients to get ahead and overcome future challenges.

Our strategic objectives could be summarized by boosting our footprint in terms of growth and geographic scope. In addition to this, we see growth opportunities in innovative areas, such as biologicals, ATMPs, biosimilars, personalized medicines, and medical devices.

According to our market research studies, we also expect an increasing demand for externalization in some specific well-established regulatory market segments and in pharmacovigilance.

Please give us a few testimonials of your clients/customers and a list of awards/recognitions that accurately highlight Asphalion’s position as a booming company in the healthcare niche.

“Thank you very much for helping us complete the submission on time, taking into account that we always send you the documents at the last minute. Your flexibility and dedication are always of great help in these critical moments,”

  • Head of Regulatory Affairs, European Biopharmaceutical Company.

“Impeccable the way you have handled this issue with so little time. Spectacular attitude and technique. Thank you,”

  • CEO, European Medical Devices Company.

“I appreciate the fact of receiving multidisciplinary support in the regulatory and scientific field,”

  • Regulatory Affairs Manager, European Pharmaceutical Company.

“It has been my privilege and pleasure to work with many executives, and my experience with you has always been excellent. Couldn’t ask for more!”

  • Pharmacovigilance Director, European Pharmaceutical Company.