MARKETING AUTHORISATION SERVICES THROUGHOUT THE REGISTRATION PROCESS: STRATEGY, MA APPLICATIONS AND LAUNCH
Planning your marketing authorisation application (MAA) early can save you time and resources while reducing uncertainty. Our experts can help you plan your MAA strategy from the beginning of the product development stage.
At this early stage, it is important to determine whether a new product can be classified as a medicine or not. By engaging early, you gain clarity on the legal basis for your application and can align your development strategy accordingly. If the product is classified as a medicinal product, the next step is to evaluate the legal basis of its marketing authorisation application. The legal basis of the marketing authorisation application determines whether the product’s efficacy and safety can be demonstrated based on literature, or whether non-clinical and/or clinical trials are required. It is also smart to get acquainted early on in the process with similar medicinal products that may already be authorised in the target countries. This can provide insights into regulatory expectations and potential positioning.
Expert support at every stage of the marketing authorisation process:
CAREFUL PROJECT PLANNING ENSURES SMOOTH MARKETING AUTHORISATION PROCESS
With over a decade of hands-on experience across both the pharmaceutical industry and regulatory authorities, our team brings deep regulatory insight to your project. By providing continuous training to our experts and constantly keeping up to date with changes in legislation, we guarantee our clients expert service that is always in line with the latest regulatory requirements. When broader expertise is needed, we seamlessly integrate our trusted partner network—giving you access to a wider range of services through a single point of contact.
Whether you’re looking for end-to-end management of your marketing authorisation application (DCP, MRP, CP, or NP) or support with specific parts of the process, we adapt to your needs. Each project is managed by a dedicated team, ensuring clear communication and continuity. By providing support for product classification and valuable advice throughout the application process, we enable fast access from research to market.
Our expert guidance covers in Europe:
- creating registration strategies
- product classifications: drugs, medical devices and food supplements
- GAP analyses of marketing authorisation dossiers
- preparation and submission of marketing authorisation applications
- coordinating application procedures.
In the United States, we will help you with
- planning of market expansion to the US
- documentation (new drug applications, abbreviated new drug applications and supplemental applications)
- market entry strategies
- product classifications
We have assisted our clients in more than 100 marketing authorisation processes
Our experience with different types of marketing authorisation procedures:
Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
“Medfiles has been a valuable partner for us during the registration and maintenance of products in Europe. They consistently provide prompt and accurate responses whenever there are inquiries or concerns related to European approvals.”
This is how a client from outside the EU, who has been working with Medfiles for 7 years, describes the partnership. The company initiated cooperation with Medfiles when they required assistance in entering the European market. The cooperation has involved applying for new marketing authorisations as well as managing products post-approval.
See also:
- Entering the EU pharmaceutical market: Q&A on new marketing authorisations
- How to write a strong Module 3 for a marketing authorisation application
- Q&A: What makes a strong Module 3 quality dossier
- How to obtain a marketing authorisation in the EU – requirements and approval process for medicinal products
- What does it take to enter the EU pharmaceutical market? Regulatory, supply chain and market access realities explained
- Marketing authorisation application processes efficiently under one roof – for all EU countries
- Meet our people: New marketing authorisations for human medicines
- Vetcare & Medfiles: Centralised marketing authorisation process for a new veterinary medicine
Other services closely related to new marketing authorisations and product launches:
ELECTRONIC SUBMISSION SERVICES (ECTD)
Preparing electronic common technical documents (eCTDs) for submission requires both the right tools and technical expertise. For many small and mid-sized pharmaceutical companies, investing in eCTD publishing software may not be cost-effective—especially when submission volumes are low.In such cases, it may be wise to save resources and outsource your eCTD publishing tasks. Medfiles uses an eCTD publishing tool that is widely used by various authorities around the world. With over 10 years of experience in eCTD publishing, we are a reliable and competent partner for all your eCTD publication activities.
We compile electronic applications in accordance with existing regulations and guidelines. In case of eCTD or VNeeS, we always use the current version of the appropriate validation tool to ensure that the compiled sequence is technically valid, and send it to the authorities using the designated channels, such as CESP or EMA Gateway.
Our team is experienced with all eSubmission formats and can consult other medical or pharmaceutical experts, ensuring the high quality of our eSubmission services. A second expert review is always included in our eSubmission price.
Our services include:
- compilation of eCTD and VNeeS sequences and other types of electronic applications
- submission of applications via the CESP portal, EMA Gateway, Eudralink, FDA ESG or secure email.
See also:
PHARMACEUTICAL PRODUCT INFORMATION AND TRANSLATION SERVICES
Our Product Information Team consists of translators and regulatory experts who have years of experience in tasks related to product information texts: summaries of product characteristics (SmPC), package leaflets (PIL) and labelling. Our competent team delivers easy to read, compliant texts tailored to the target audience, even within strict schedules. Using computer-assisted translation and translation memory tools, we ensure consistency in terminology and style across all documents. Regulatory review is included in our process, and we employ the four-eyes principle to guarantee the highest possible quality.
Our services include:
- preparation of product information text
- translations of product information texts
- in Finnish, Swedish, English, Estonian, Latvian and Lithuanian
- other languages through our partner network
- package leaflet user tests and bridging reports
- proofreading of mock-ups
- preparation and updating of abbreviated SmPCs
- updating national medicines compendia.
By partnering with us, you gain more than just translation—you gain a trusted team committed to delivering product information that supports both regulatory approval and patient understanding.
See also:
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations of vet medicines
- Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
Readability Testing & Bridging Reports for EU Marketing Authorisation Applications
Ensuring that your package leaflet is understandable to patients is a regulatory requirement under Directive 2001/83/EC. That’s where our expertise in readability testing and bridging reports comes in.
Readability Testing
We conduct structured user consultations to verify that your leaflet is:
- Clear and legible for the target patient population
- Comprehensible in terms of dosage, warnings, and instructions
- Compliant with EMA and national authority expectations
Our process includes recruiting representative users, conducting iterative testing, and delivering a comprehensive report ready for submission.
Bridging Reports
If your leaflet closely resembles a previously approved version, a bridging report may be sufficient. We help you:
- Identify eligible reference leaflets
- Justify layout and content similarities
- Prepare comparative analyses
- Submit a robust, regulator-ready report
price and reimbursement applications
Once a marketing authorisation has been granted, the marketing authorisation holder can apply for the inclusion of the medicinal product in the national drug reimbursement system. Also, medicinal products for which a special permit has been granted, clinical nutrition products, or basic ointments may, under certain conditions, be eligible for reimbursement in Finland. Reimbursement and wholesale price decisions are usually granted for a period of either 3 or 5 years. After this, a renewal application is required unless the medicinal product is part of the reference pricing system.
We can help with the following tasks:
- price and reimbursement status applications
- marketing authorisation renewal applications
- price comparisons and price level determinations
- reference price declarations.
insights on new marketing authorisations
Our expert team regularly writes blogs on human regulatory affairs, covering topics such as regulatory strategy and marketing authorisation applications.
Medfiles’ regulatory affairs services in figures
30+
YEARS OF EXPERIENCE – services from 1990
40+
REGULATORY EXPERTS WITH AVG. 11 YEARS OF eXPERIENCE
75+
CLIENTS IN 18 COUNTRIES
(EU, ROW)
450+
eSUBMISSIONS / YEAR
Contact us
You may also be interested in:
- Selected non-prescription medicines to be sold outside pharmacies in Finland
- Entering the EU pharmaceutical market: Q&A on new marketing authorisations
- How to write a strong Module 3 for a marketing authorisation application
- Q&A: What makes a strong Module 3 quality dossier
- What does it take to enter the EU pharmaceutical market? Regulatory, supply chain and market access realities explained
- How companies developing human and veterinary medicines can benefit from SME status in the EU
- How to obtain a marketing authorisation in the EU – requirements and approval process for medicinal products
- Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
- Marketing authorisation application processes efficiently under one roof – for all EU countries
- Meet our people: New marketing authorisations for human medicines
- Free guide: What you need to know about active substance registration strategy?
- Vetcare & Medfiles: Centralised marketing authorisation process for a new veterinary medicine
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Longer lifecycles call for better quality – changing your eCTD publisher might be the solution