Specialized product expertise where it counts

RegPak BioPharma Consulting specializes in regulatory affairs consulting services relating to pharma and biological products and has focused on this field for over 12 years. It has assisted clients from Europe, the United States, Australia, and India for their innovative product development. This extensive experience, with a proven track record, places

When you partner with us, you engage a team of experts, each with technical and industry specializations.

Our services include

  • Early Access/Compassionate Use

    Experience in planning and applying for Early Access Program authorizations in various countries worldwide. These programs ensure access to unapproved but promising medicinal products on compassionate grounds for unmet medical needs.

  • Orphan Designation

    We can help to develop the best suitable regulatory strategy, apply for orphan drug designations in Europe and US, prepare for and attend at EMA & FDA meetings.

  • Scientific Advice

    We can help in obtaining the best possible agency feedback by selecting the most appropriate regulatory authority in the EU or non-EU authorities as needed. Our team will lead the entire advice procedure on behalf of the client.

  • Quality

    Suspendisse ut libero augue. Maecenas feugiat, nulla eget maximus elementum, odio augue placerat est, nec semper nisl erat ac ex el convallis ligula commodo ac. Aenean congue. Nunc eu tellus pellentesque!

  • Medical Devices

    RegPak BioPharma Consulting provides a full range of consulting services for the development and registration of medical devices. We have vast experience in all aspects of this field.