REGULATORY AFFAIRS SERVICES FOR HUMAN MEDICINES – TAILORED SOLUTIONS FROM STRATEGY TO LIFECYCLE MANAGEMENT

We have been supporting clients with regulatory affairs services for over 30 years, working with companies ranging from early-stage start-ups to fully established multinational corporations. With expertise across global, regional, and local regulatory frameworks, we support your products through every stage – from regulatory strategy and initial submission to launch, lifecycle management, and maintenance of established portfolios.

Our team of some 40 highly qualified regulatory professionals is based in Finland, Estonia, Latvia, and Lithuania. We combine in-depth regulatory, CMC, and scientific expertise to help you manage challenging regulations efficiently – minimising risk, accelerating time-to-market, and maximising return on investment for your approved products.

In addition to our human and veterinary regulatory affairs expertise, we provide pharmacovigilance services for both human and veterinary products – conveniently under the same roof. This integrated approach streamlines your operations, ensuring seamless compliance across all regulatory and safety requirements with a single trusted partner.

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REGULATORY AFFAIRS SERVICES THROUGHOUT THE PRODUCT LIFECYCLE:

Read more about our regulatory affairs services for human medicines

CMC expert services and CMC consulting

Our CMC team works hands-on to support the development and registration of your medicinal product – human or veterinary. With long experience in analytical chemistry, pharmaceutical manufacturing and with regulatory agencies, we know how to turn complex data into clear, compliant Module 3 / Part II documentation. Whether you’re starting from scratch, updating existing Module 3 documentation, expanding to EU from other regions or facing tight deadlines, we offer practical, science-based solutions that fit the real needs of your project and timeline.

New marketing authorisations

We help you get your product approved in the EU – whether it’s a human or veterinary medicine. Our team works closely with you on every step of the MA process: planning the right regulatory strategy, compiling and reviewing dossier content, handling submissions, and managing questions from authorities. We know the requirements inside out and act fast when timelines are tight. You can rely on us for practical support that fits your way of working, with the option to combine services like CMC, clinical, e-submissions, and PV into one coordinated package.

Marketing authorisation maintenance

We help keep your marketing authorisations up to date and compliant. From managing variations, renewals, and transfers of MA to a new holder to handling regulatory updates, labelling changes, and local requirements across EU markets, our team works as an extension of yours. Whether you need help occasionally or ongoing support, we step in quickly, adapt to your systems, and keep things moving without delays.

Local regulatory affairs services

Medfiles offers hands-on help with national procedures, translations, labelling updates, promotional material reviews, and authority communication especially in the Nordic and Baltic regions. With strong local presence and trusted partners, we handle the details so your product stays compliant and on the market. We also offer services under Good Distribution Practice (GDP) and can act as your Responsible Pharmacist in Finland.

Regulatory affairs services in EU and USA

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)

Why outsource regulatory affairs services to Medfiles?

Medfiles has extensive experience in human and veterinary medicinal products, including sterile and non-sterile products and biological medicinal products. Our team of 40 experts consists of specialists with educational backgrounds in pharmacy, natural sciences and chemical engineering. To ensure the high quality of our services, our experts undergo regular training and are always up to date with the latest requirements and practices.

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Explore different outsourcing models

We are ready to help you with a wide range of regulatory tasks related to your product’s lifecycle, whether your company is a small or medium-sized business, a large enterprise or an academic research organisation.

Our expertise benefits e.g.:

non-EU companies that need expertise in the pharmaceutical legislation in the EU
companies that have not previously had products classified as medicinal products in their product portfolio
companies that want to outsource routine tasks and prioritise their time for something else, such as new product development projects
companies facing surprising or challenging changes in their resources. Ask for a part-time or full-time expert, for short- or long-term outsourcing.
companies with products in many different product categories: human medicines, veterinary medicines, medical devices, IVDs and food supplements. We have highly qualified and experienced teams for each of the different product categories. In case of borderline products, our teams work closely together to help you select the right registration route.
companies with projects that require broad expertise: our service portfolio includes clinical trial, regulatory affairs and pharmacovigilance services.

We offer transparent and adaptable pricing models to suit your needs:

Hourly-based consulting for ad hoc or irregular tasks
Hourly pricing with estimates for larger projects – combining flexibility with predictability.
FTE-based insourcing for long-term, dedicated support