Regulatory Affairs services

We have been providing Regulatory Affairs services since 1991 for 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 providing correspondence for authorities.

Product registration

As experts in product registration with the competent national authorities, we can offer you help in:

  • National registrations
  • Decentralized procedures 
  • EMA registrations

Our scope of activities include Regulatory Affairs services for the following product groups:

  • Pharmaceuticals
  • 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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