Inthera has been a trusted provider of pharmaceutical services since 1991. Comprehensive pharmaceutical regulatory support is one of the services that caters to manufacturers globally. Specializing in Hungarian and European regulation, we offer a diverse range of services, including professional translations, dossier submissions, and correspondence with pharmaceutical regulatory authorities.

Pharmaceutical product registration

We can offer you full scale services in the three most common procedures
for pharmaceutical registrations in the European Union:

National registrations

With over three decades of experience, we have established strong relationships with the National Institute of Pharmacy and Nutrition (NIPN or NNGYK in Hungarian), enabling us to expedite product registrations on the Hungarian market efficiently and cost-effectively.

Decentralized registrations

If your strategy involves launching products simultaneously across various European countries, decentralized procedure for pharmaceutical registration becomes imperative. We are fully equipped to handle this type of product registration as well.

EMA registrations

Certain therapeutic groups, such as oncological products, vaccines or treatments for diabetes, require a registration with the European Medicine Agency (EMA) instead of a national or decentralized registration. Our company provide comprehensive EMA registration support tailored to each client's needs.

Additional pharmaceutical services

In addition to product registrations, Inthera offers a suite of supplementary services essential for pharmaceutical regulatory compliance and market success:

Preparation for EU GMP audits

(review of relevant SOPs, GAP analysis, online and in-person site inspections, suggestions for corrective measurements etc.).

Assembling of dossiers in eCTD format.

Advising for all 5 modules of the dossiers

(administrative modules, expert reports, modules on active substances and finished products, pre-clinical dossiers and clinical dossiers).

Translations of packaging,

leaflet, documents and certificates into all languages of the European Union.

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Why choose us?

What truly sets us apart is our comprehensive approach, combining regulatory expertise with market insights gained through decades of experience as pharmaceutical service provider. 

By choosing Inthera as your pharmaceutical regulatory affairs partner, you gain access to a wealth of knowledge and personalized guidance, ensuring regulatory compliance and market success in an ever-evolving pharmaceutical landscape.

Contact Us!

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out to us with any inquiries or feedback – we're here to assist you!