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A Finnish company is digitalising the process of writing marketing authorisation applications – the sections describing the medicinal product’s manufacturing and quality can be completed in half the time with the new DRA Variator® software.
Finnish pharmaceutical industry consulting company DRA Consulting has developed a piece of software that automates and speeds up the writing of a marketing authorisation application, resulting in it taking only half as long as it used to, while reducing the risk of error. Thanks to the innovation, medicinal products can reach patients and health care providers more quickly. At the same time, experts’ time is freed up for the more challenging parts of the process. This is a groundbreaking innovation in the pharmaceutical industry. The new DRA Variator® software is based on creating and processing XML documents, making it compatible with the new digital solutions of the European Medicines Agency.
The Finnish DRA Consulting has developed a groundbreaking piece of software that speeds up the process of applying for marketing authorisation for medicinal products. The software, which digitalises traditional expert work, saves time and money and frees up experts’ time for the more challenging parts of the process.
“The faster the documentation for the application can be created at the end of the development process, the faster new medicines can be placed on the market to benefit patients,” says DRA’s Managing Director Kaija Korpiaho-Haga.
DRA Consulting is one of the largest pharmaceutical industry consulting firms in Europe. Its mission is to help pharmaceutical companies offer new medicinal products to patients and health care providers.
“DRA is like a pharmaceutical industry lawyer for every phase of a medicinal product’s life cycle. The industry is strictly regulated, and placing and keeping a medicinal product on the market requires continuous regulatory work. The marketing authorisation is based on an extensive demonstration of the medicinal product’s efficacy, safety and quality using clinical trials. Creating this documentation takes time and requires special expertise. Fortunately, you no longer need to handle papers and binders, as the marketing authorisation application process can now be done digitally,” Korpiaho-Haga says.
“The marketing authorisation applications for medicinal products are usually created by pharmacy experts, such as those with a doctoral, master’s or bachelor’s degree in Pharmacy. To help them focus on what is most important, we have created a piece of software that automates the routine part of expert work. The DRA Variator® software speeds up the process of creating an application and advises the user in parts of the process that require special care,” Korpiaho-Haga says.
There is an international market for the new software
The new software is groundbreaking in the pharmaceutical industry, and the project has also received funding from Business Finland. The software speeds up medical and technical writing by taking the recorded information and converting it to structured XML format and repeating the information automatically in other sections of the application. Thanks to the automation, updating the documentation is easy, as the user only needs to make the change once in a single location. This frees up experts’ time for the more challenging parts of the application.
“Like coders, experts in our field are in very high demand. In addition to bringing benefits to clients, digitalisation and software development is also an investment in the staff’s job satisfaction. We want to offer motivating and interesting work where experts are able to fully use their expertise,” Korpiaho-Haga says.
The DRA Variator® software is currently being tested internally at DRA, but there is already international demand for the innovation.
Even though changing the current system and taking full advantage of structured data require wide-ranging international co-operation between authorities, structured data will gain ground in authorisation processes.
“The pharmaceutical industry simply cannot afford to not take advantage of the opportunities offered by new solutions,” says the person who came up with the idea for the software, DRA’s R&D Director Eija Hartikainen.
“I believe that, in a few years, DRA Variator® will be widely used in the international pharmaceutical industry and its benefits will be seen in practice. Fimea, the authority supervising the Finnish pharmaceutical industry, performed 32,692 marketing authorisation tasks in 2020. If all countries averaged the same number of tasks, the annual number of tasks globally would be about 6.5 million. A large share of the tasks are related to applications, which could be created using DRA Variator®, saving a huge amount of time and money,” Hartikainen says.
Considerable growth in the number of employees during the COVID-19 years
The number of people working for DRA Consulting grew by about 30% in 2020 and 2021, and the company currently employs a little over 100 people. The record growth was brought about by factors such as clients’ need to make their operations more efficient as well as mergers and acquisitions, which have created demand for outsourced expert services. DRA’s clients include more than 300 companies making medicinal products and medical devices. A third of these companies are international.
DRA has grown steadily and profitably for the entire 19 years it has been operating. In 2020, the company’s turnover exceeded EUR 10 million, and the growth has continued in 2021. DRA continuously invests in the well-being of its staff, which is reflected in the company’s excellent employee experience.
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DRA Consulting is a Finnish pharmaceutical industry consulting firm founded in 2002. We offer services and consulting related to marketing authorisations of drugs and medical devices, price applications, pharmacovigilance, wholesale activities and marketing. We operate in the Nordic countries and throughout Europe. We are a founder member of the Europe-wide EuDRAcon network of pharmaceutical industry consulting firms.
Source: Fimea’s number of marketing authorisation tasks in 2020