Regulatory Support

Your regulatory affairs in good hands

Regulatory Support

Your regulatory affairs in good hands

Inthera has been providing full scale of regulatory affairs services since 1991 for various manufacturers of different pharmaceutical products both inside and outside the European Union. Our main scopes of activity are Hungarian and European regulatory services, professional translations, preparation of our clients for EU GMP audits, along with submission of dossiers at different regulatory bodies and providing correspondence for authorities.

Product registration

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

National procedures

Thanks to our great relationship with the Hungarian pharmaceutical agency (OGYÉI) and our 30 years of experience, we are able to register your products on the Hungarian market in a quick, efficient and cost-saving way.

Decentralized procedures

If you plan to launch your products in multiple European countries at once, you will require a decentralized procedure for registration. However we got you covered for this type of product registration too.

EMA registrations

Certain therapeutic groups such as oncological products or treatments for diabetes require a registration with the European Medicine Agency instead of a national or decentralized registration. 

Product groups

To ensure your success, we can help you in providing registrations and regulatory support for the following product groups:

Pharmaceuticals

Medical Devices

Nutritional supplements

Cosmetics

Additional services

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.)

Support in organizing and performing clinical trials & bioequivalency studies​

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

Why choose us for Regulatory Affairs services?

Besides our 30 years of expertise at Regulatory Affairs services, we have a long history as pharmaceutical wholesaler and distributor. Therefore we have an enormous network spanning across the entire European Union with different wholesalers and authorities. This not only enables us to help you in bringing your product to the market in a quick and effective way, but also in sharing valuable market insights about which products you should register in different countries. With our market expertise we can help you in determining the right approach to different markets with various product groups. In other words: by choosing us as your Regulatory Affairs service provider, we not only carry out the basic RA tasks, but guide your way to the market with expertise and knowledge carefully acquired over three decades.

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