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Asphalion | Núria Romero

There are many reasons why new drugs are important, such as new diseases, the development of drug resistance, and our increasing understanding of health conditions allowing treatment of previously untreatable conditions.

To maintain our health, we need to be able to fight against well-known and increasing health conditions, such as cardiovascular disease, which has adverse effects on almost seventeen million people a year, and recent infections like COVID-19, which can massively disrupt the world and affect millions of people in the first year it occurs.

With a mission to work together with its clients to create ideas and implement solutions that contribute to improving health in people’s lives by delivering the best possible solution, Asphalion offers multiple services during every drug development stage.

Under the leadership of Núria Romero, the Managing Director, digital solutions for regulatory affairs have been a priority in Asphalion for almost 15 years. The company also offers support in assessing its clients’ situation by defining their specific business and regulatory needs, helping them choose the right solutions, and supporting the entire implementation process until end-user training.

In an interview with Insights Care, Núria shared valuable facts that highlight Asphalion’s significance in the healthcare industry.

Below are the highlights of the interview:

Please brief us about the company and its inception.

Asphalion was founded in 2000 by a group of pharmaceutical R&D professionals with the vision to offer high-quality services for developing and registering innovative drugs. Within a few years, our team and client had proliferated, and we established specific teams per service area, which evolved into the eight service units we have today.

In 2008 we defined the internationalization of our service capabilities and our customer base as a strategic objective. We built a network of worldwide partners, increased the number of international staff at Asphalion, and focused our commercial actions on new markets.

After many years of continued organic growth, Asphalion has grown into a leading consultancy with over 160 team members, clients of over 1,000 companies, and a track record of over 5,000 projects. We offer comprehensive support for all regulatory, scientific, and safety activities while developing, registering, and commercializing medicines and medical devices.

What are the core values that the organization stands by? What is its mission and vision statement?

We want to be the preferred partner in outsourcing of scientific, safety, and regulatory affairs: our quality and expertise are our core strengths and allow us to adapt ourselves to any request. Our organization’s values are passion, flexibility, commitment, quality, and companionship. Our team’s mission is our passion: Working with our clients to generate ideas and implement solutions that improve 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, in your opinion, are the key challenges in the healthcare sector? How is your company turning those challenges into opportunities?

Successful development and commercialization of medicines and medical devices remain a challenging business. Apart from the obvious point of funding and budgetary constraints, the availability of skilled staff, implementation of new technology, and risk management are critical challenges for pharma, biotech, and MedTech companies.

Regarding the availability of skilled staff, many companies need help to upskill their existing team or find new professionals. This point is particularly relevant to the second challenge, implementing new technology, which requires a unique talent for innovation and transformation. Obviously, this situation is a direct opportunity for us, and, on the one hand, it made us develop specific training services for our customers. On the other hand, it led us to offer continuous collaboration models to compensate lack of qualified staff within companies.

The second key challenge I see is the implementation of new technology, which nowadays is a universal business requirement for all companies in the healthcare sector due to new electronic standards imposed by regulations and agencies, as well as economic considerations linked to operational efficiency and resulting market competitiveness. Companies need help in this area due to problems in defining the correct internal requirements, choosing the adequate solution in various possible options, or practical aspects during implementation.

As mentioned initially, digital solutions for regulatory affairs have been a priority in Asphalion for almost 15 years. We offer support in assessing our clients’ situation by defining their specific business and regulatory needs, helping them choose the right solutions, and supporting the entire implementation process until end-user training.

Finally, risk management remains a crucial challenge for pharma, biotech, and MedTech companies. We all know that drug development is a costly and risky business, as many drug candidates end up failing. There are several ways to mitigate the related financial risks, and one of them is applying regulatory intelligence from the beginning of drug development. During the last decades, regulatory affairs have transformed from a collection of technical and administrative requirements to a critical part of the development strategy, which, if done well, adds significant value to the project.

What we offer in Asphalion is a team of seasoned regulatory experts that understand all procedural and formal aspects by heart in combination with scientific experts that are up to date with the latest changes relevant to the development of innovative drugs, biologicals, ATMPs, and combination products. By designing a thorough regulatory strategy for our clients, we effectively reduce part of the inherent risk in drug development.

What are the key products and services offered by the company? How is it impacting the concerned demographic?

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 commercialization & post-market. We have strong expertise in different types of products, including highly complex ones such as Biologics & ATMPs.

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

In which ways is the company adapting and including constant technological upgrades? How has it impacted the company growth curve?

A strategic objective for our company was the early adoption of electronic standards in Regulatory Affairs. We were one of the first consulting firms to submit registration dossiers in electronic format to European agencies, which instantly became a cornerstone service in Asphalion.

In parallel with creating internal expert teams, we entered into partnerships with software and technology providers and started offering our clients software implementation and training support. Up until today, digital transformation has been a strategic imperative in all our internal plans and projects with clients.

Electronic regulatory affairs services significantly impacted our growth curve. For example, with the beginning of electronic dossier submission in eCTD format in Asphalion in 2008, we quickly created a new services team. We entered into collaboration with numerous companies facing the challenge of complying with the latest regulatory requirement.

In the same way, our growth curve is positively impacted by services like pharmacovigilance database outsourcing, compliance with xEVMPD requirements, implementation of RIMS, and adaptation to the IDMP standards.

What are your company’s future goals, and how has it envisioned scaling its operations and reach in 2022 and beyond?

As a privately-owned company, where all shareholders are active employees, we have the distinct luxury of focusing on our passion, which is being a trusted partner for our clients and jointly achieving healthcare advances that benefit every one of us. In this sense, most of our goals are focused on the continuous improvement of our service teams and expanding our service capabilities while maintaining financial independence and continued organic company growth.

However, an excellent and motivated team can only achieve all this. In this sense, we set the highest priority on making Asphalion one of the best places to work at. For example, our People and Culture department continuously supports our staff in the ever-changing dynamics of today’s work culture. In addition, we celebrate several team events each year to keep our staff connected and to enjoy good times together.

As in the past years, one of the transversal strategic company objectives is to continue our journey towards digital transformation for further improvement of internal processes, as well as to be capable of assisting our clients with all challenges related to the digitalization of regulatory and scientific affairs.

Lastly, to adapt to the rapid growth of our team, we run numerous projects to strengthen our internal departments and processes, thus making sure that our growth does not make us bureaucratic or less flexible.

The Adept Leadership

Núria Romero, Asphalion’s Managing Director, started working at Asphalion 20 years ago and was appointed CEO in 2016. She brings over 20 years of regulatory affairs and consulting experience in the pharmaceutical industry as a Regulatory Affairs Consultant, as well as 15+ years as Regulatory Affairs Operations Manager at ASPHALION.

She actively participates in scientific and technical meetings with competent authorities from Spain, Europe, and the US. Núria has a Pharmacy Degree, postgraduate studies in Quality Management and ISO 2000, an MBA from IESE Business School, and a postgraduate in Sales and Digital Marketing from ESADE.

Testament of the Services

“To everyone: Many thanks for your support; this is a great milestone achieved. When we started, we thought it would be challenging, but this is a clear example of cooperation.”

  • Regulatory Affairs Director at an international Big Pharma Company:

“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.

“I am quite sure that this might not have been possible should there have been a less skillful, experienced, and committed partner supporting us other than Asphalion. Your contribution is huge and is deeply appreciated.”

  • Life Science Software solution provider.

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