As a trusted Irish pharmaceutical company, Rexpharma provides outsourced clinical QP services and Quality support for your products
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At Rexpharma our QPs certify & release your clinical products to enable your IMP reach EU clinical trials
Our experienced team supports your entry into the EU with our bespoke Quality & Regulatory guidance
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We are your outsourced EU partner for clinical QP batch release & certification service using our HPRA-issued clinical QP authorization (IMP MIA).
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Rexpharma specializes in supporting clients entering the EU & ROW markets by offering Quality and Regulatory guidance.
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We support phase I-IV products, and have broad expertise in biotech, biologics, ATMPs, combination products, and small molecules.
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Our services also include quality audits, QP declarations, Quality System design, outsourced quality department (QaaS), supply chain optimization, and training/artwork development.
We provide a bespoke, tailored approach to supporting your business, letting you the Client advise the direction and pace of your EU clinical trials.
Our experienced team has extensive EU QP & regulatory knowledge and insight you can rely on when setting up your clinical trials in Europe.
Our regulatory team secured our QP license and GMP certificate in under 90 days, offering direct QP support and EU insight for your projects.
Our QP team will provide a declaration to support your clinical trial application in the EU.
We act as your EU operation under our license, saving you from setting up your own and handling EU regulatory, legal, and financial complexities."
Our audit capabilities are extensive and varied, able to tackle any audit project when selecting EU vendors
Once ready, we have in-house pedigree of launching clinical and commercial products all across Europe and North America
Over 40 years cumulative commercial and pharma experience in our Executive Team
Quality experience leading over 32 successful clinical trials
-Clinical MIA (QP)
-Commercial MIA (QP)
-Wholesale/Distributor Authorization (RP)
-Controlled Drug License
Our proficient regulatory function has been able to secure our clinical QP license and GMP certificate in less than 90 days from application.
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Contact Rexpharma today to learn how we can support your and launch your EU clinical trials program. Our experienced team is here to help you navigate the complexities of the EU market with ease.
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We are clinical specialists that provide small-to-medium size businesses access to the EU for their new/existing clinical trials. We do this by adding your drug(s) to our in-house license (IMP MIA) and our QPs get your products into trials by certifying for release in the EU/ROW.
We support your regulatory applications with in-house QP Declarations needed for your Clinical Trial Application/Variations.
We manage your supply chain and provide bespoke audit services to you company and supplier network to ensure EU compliance, as well as training and Quality/QP support on your projects.
We deal with everyone from one person & a molecule, all the way up to large corporate entities. We have structured our business to serve small-to-medium enterprises best.
This is readily accommodated, and part of our business model. Do reach out to learn more here.
We ideally will start the onboarding process 6-12 months out from when the Client needs QP certification. We do offer expedited onboarding and expedited certification/release services.
Our strategy is to list as many suppliers on our license as possible so we can expedite your onboarding. We expect initial onboarding to take 3-6 months depending on the complexity of your operations.
