Aristotelesstraat 18, 1064 LD, Amsterdam
Street Victor Brauner no. 400, Bl. 1, Ap. 13, District 3, Bucharest, Romania
+31 (0) 629075858
info@regpakbiopharma.com
OUR EXPERTISE

Navigating Regulations, Ensuring Compliance, Delivering Excellence.

Product Auth./Market Approval
Product Authorisation/ maintenance

It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and their extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions. 

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Medical Devices
Medical devices approval

RegPak has full range consulting capabilities across the globe, including an all-inclusive medical device consulting service offering. Our medical device consulting capabilities include all regulatory, clinical and quality compliance aspects of device, diagnostic and combination product development.

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Pharmacovigiliance
Pharmacovogilance

The ultimate goal of pharmacovigilance is to appropriately handle information concerning adverse drug reactions and to protect the public from emerging safety issues throughout a medicine’s lifecycle.

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QP & Batch Release
QP & Batch Release

RegPak has the expertise to handle medicinal products all the way to QP release. Whether for commercial sale or clinical trial use, a finished product must be certified and released by a Qualified Person (QP). This process is known as a QP release.

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Discovery/ Non-Clinical
Discovery / Non-clinical
RegPak can provide you with an end-to-end project plan to guide clients from the development of your product right through to authorization and beyond.
A wealth of expertise in clinical research exists within RegPak BioPharma Consulting. Our team of experts are in regular agency contact and represent the cutting edge of clinical research programs.
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