Access Program authorizations in various countries worldwide

A wealth of expertise in clinical research exists within RegPak BioPharma Consulting. We have extensive experience of the preparation, submission and approval process for clinical trial applications in major clinical trial conducting countries. Our team of experts are in regular agency contact and represent the cutting edge of clinical regulatory affairs.  RegPak BioPharma Consulting can offer specialized consultancy advising on clinical and regulatory strategy for new product development, design of clinical trial protocols and preparation of applications for Clinical Trial Authorizations.

Our services include

  • Early Access/Compassionate Use

    Early Access Program authorizations in various countries worldwide. Access to unapproved but promising medicinal products for unmet medical needs.

  • Orphan Designation

    Apply for orphan drug designations in Europe and US, prepare for and attend at EMA & FDA meetings, and advise on establishing relations to important patient advocacy groups.

  • Scientific Advice

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  • Quality

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  • Clinical Trial Service

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