Introducing Our Scientific and Technical Affairs Team

Each member of the Medis Scientific and Technical Affairs team plays a key role in offering Medis customers dedicated and specialized support in a variety of complex and highly technical matters, with the ultimate goal of ensuring successful dossier submissions, marketing authorization approvals, and continuous product supply.

Scientific Matters, Market Requirements & International Market Support

Medis has a portfolio of 185+ products, which are mainly in EU CTD format. Since Medis has a presence in multiple countries outside of Europe, this means that Medis and its customers must adapt the dossier for local regulations and market requirements.

Such requirements might range from simple additional documentation to extensive stability studies in different stability zones, additional analytical methods, or even new biostudies. Helping to evaluate the additional needs in line with market requirements is a key function of the Scientific and Technical Affairs department.

Meet Carola Frank who holds a Ph.D. in Health and Human Performance and has been in the pharmaceutical industry for over 20 years.

Carola has throughout her career worked in Regulatory, R&D Project Management, Technical Product Transfers and Business Development, before becoming the Director of the Scientific and Technical Affairs Department at Medis.

She provides scientific and technical advice both to clients and internal Medis functions. Whenever discussions on a certain issue become more complex and need some scientific or technical analysis, she jumps in to support, and to do the research necessary for finding a solution.

In her off hours, Carola coaches tennis (she used to be a competitive tennis player!). She believes there is a strong connection between succeeding in sports and succeeding in business. She also feels that coaching athletes isn't so different from leading your team in business – it’s about identifying the potential of each team member and enabling them to maximize it. Carola loves competition, be it on the tennis court or in the pharma industry, and as she succinctly puts it, “in Medis, we have the privilege to partner with our customers in this competitive landscape, and to help them succeed.”

Serialization

In early 2019, the European Pharmaceutical industry began the mandatory implementation of a track-and-trace system to help secure a safe supply chain and combat counterfeiting.

Serialization is therefore implemented nowadays in most European countries and is little by little also being introduced in other territories worldwide. The process of serialization involves assigning a unique identifier to each finished product pack, to be able to trace it from the moment it leaves a manufacturing site to the point it reaches the hands of the consumer. All information is then kept in a unique database, using the unique identifiers for authenticity.

Serialization activities include IT connectivity, digital barcodes, data matrix, complex databases, system configurations, client onboardings and master data management. To make all these activities happen smoothly, it is important to have technical experts behind the scenes to support our customers.

Meet Eva Hatzikonstantinou, Medis’ Serialization Manager, based in Athens, Greece.

Eva is a Global Serialization and Customer Liaison Manager at Medis with 10 years' experience in the pharmaceutical field, responsible for the implementation of worldwide serialization legislations. She holds a Master's in bio entrepreneurship and a certification in project management, and she has previous experience in Customer Service, Plant and Quality Control departments.

On the day-to-day, she handles communications with customers worldwide and multiple internal & external departments to ensure Medis is aligned with serialization regulations. She is responsible for maintaining the serialization master data in the track and trace systems.

She’s a friendly, warm character and has the soft skills to interact with different people, departments and authorities. “It is important to coordinate and solve a serialization technical issue fast to be sure that the product is compliant & supplied according to territory’s legislation. In the Scientific and Technical Affairs department, I like that I can combine interaction with people, constant learning about new regulations and the very technical side of my daily work.”

Commercial Regulatory Support

Medis offers unique individualized support to its clients by providing regulatory experts with deep scientific and regulatory expertise to accompany them in their regulatory journey, both from the initial stages in product identification and evaluation, as well as through regulatory submissions, approvals, and life-cycle management.

The commercial regulatory managers provide specialized support to Medis clients by managing and addressing complex scientific and technical issues, while accompanying the client throughout his journey with Medis.

Meet Ana Carolina Montanholli, who is based in Brazil. She is the newest member of the team and, in her role, supports current customers as well as new business opportunities in the LATAM region.

Ana is a pharmacist with more than 20 years of experience in the pharma industry. Her analytical, clinical, and regulatory background gives her critical and detailed knowledge of the dossier gap analysis she performs. She also brings extensive experience in dealing with customers worldwide and leading international teams in her previous companies.

Ana values teamwork and believes that prioritizing human interaction is the key to success. She is a great asset to Medis, strengthening the company´s focus on expanding opportunities, and offering greater support to LATAM clients to expedite their registrations and achieve prompt product supply.

While the LATAM regulatory scenario has a challenging history, Ana believes there are current efforts to foster the availability of drug products faster. She monitors the industry closely and feels that the advances in methodologies, use of references, and access to modern tools, will allow the agencies to adopt accelerated pathways to grant registrations promptly.

What keeps Ana ready and going is running! Anytime she can, she starts her days running, preferably close to nature.

Meet Gabrijela Matanovic, who is the team's dedicated regulatory person for all things APAC related! Gabrijela is based in Sydney and works around the clock (literally!) to support Medis´ clients with specialized guidance on regulations and regulatory strategies for the region.  

Gabrijela has been in the industry for over 20 years and was awarded a Ph.D. in Pharmacology. Her Honors and Ph.D. projects included development of assays for both small molecules as well as large proteins. This experience has been invaluable in one of her key activities — dossier gap evaluation.

While Gabrijela must always be acutely aware of individual regulatory matters for each territory, she explains how there are current efforts being made globally to harmonize some of the requirements. Some of the region´s regulators, such as the Therapeutic Goods Administration (TGA), are working hard with other global regulators to reduce streamline processes to get faster approvals for multiple markets. "Patients need this, and it can be done if we all work together."

With her can-do attitude and positive approach (within the realm of the law), it is very fitting that what Gabrijela likes about her role, is that "no two hours are the same". She understands the importance of her position and the significance of thinking on your feet — "You have to move strategically to ensure the best outcome for the patient, the customer and the company. It's a three-way partnership and that's what I'm here for."

Meet Svava Bragadóttir, who is based in Iceland. Svava is a pharmaceutical technician and has been with the company since 2003, after a brief stint working with originator companies, and then coming back to Medis with a renewed appreciation of the faster-paced world of generics.

Svava serves as the main commercial regulatory support for key customers in the European market. She coordinates and interacts with customers, and many Medis internal functions, such as the Submissions team, the Life-cycle Management team, the Quality team, Commercial Operations, and many others. She thinks strategically with the client, working on regulatory prioritizations, timelines, new requirements, variations, and other regulatory concerns.

A big part of what Svava does involves coordination with all other departments to best serve the customer. She finds it refreshing working with multiple clients in various markets as it is complex and challenging to keep on top of all the European regulations and market requirements.   

Svava thinks the way to deal effectively with her role is to be super organized. There are many customers, many variations, and many things happening at the same time, but as long as you can keep it all in check, it's completely manageable.

And if she needs to have a bit of a breather, Svava heads to the nearest mountain (about 10 minutes from her home) for some beautiful Icelandic nature and a boost of energy. In fact, the day we spoke to Svava, she was heading out for a hike after work with some of her colleagues, as part of a new health motivation initiative in the office.

It is this unique and specialized team that offers Medis clients scientific and technical value-added solutions to accompany them throughout their product journey, giving Medis an edge in the out-licensing business.

If you want to learn more about how the scientific and technical affairs team, or any of our other departments, can help you and your company throughout your out-licensing journey, please feel free to reach out to us today!