At Rexpharma, we are dedicated to delivering bespoke certification and QP support for clinical and biological products
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Rexpharma is an agile Irish pharmaceutical services company that enables clinical manufacturers in the US, UK, Japan, and other markets import and QP certify their products.
Founded by Irish Entrepreneurs
Founded by a team of Irish serial entrepreneurs in 2023, this dynamic company holds a clinical Manufacturers Importers Authorization (IMP MIA).
Supporting Global Clinical Imports
Using this QP authorization, Rexpharma supports clients in importing and QP batch certifying their clinical products into Europe. We help rationalize your supply chain and audit new suppliers locally and in the US.
Actively Onboarding New Products
There are several exciting projects ongoing at Rexpharma, and we are actively onboarding four new products to our authorization.
Expanding US and Global Client Base
The company is focused on growth in the US market, currently supporting two US clients with pre-clinical and phase I/II biologics products. We are also actively interested in acquiring clients in the UK, Japan, China, and Switzerland.
Managing Director
info@rexpharma.ie
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Helen Dunne is our Managing Director and as a proven commercial leader in a wide variety of industries.
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Helen manages the overall business and commercial operations at Rexpharma.
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Other roles Helen holds at Rexpharma are as our GDPR Data Officer and as the Company Secretary.
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Helen has over 20 years’ experience is a range of sales and executive roles from business development, sales, marketing, and commerce.
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Helen is also an Executive Director and Company Secretary of Bicopharm Limited, a pharmaceutical consultancy company.
B.Sc., M.Sc., M.Sc., MBA, MRSC
Chief Technical Officer
willc@rexpharma.ie
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Will Conway is our Chief Technical Officer leading the technical operations function and is also our Rexpharma Chief of Staff.
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Will brings two decades of pharmaceuticals experience in Quality and Regulatory functions and 10 years in management & executive functions.
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He is an experienced clinical & commercial QP, RP, & controlled drugs officer.
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Will is also an Executive Director and Managing Director of Bicopharm Limited, a pharmaceutical consultancy company.
Experience and expertise:
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Prior to becoming a consultant, Will worked as Head of Quality & Regulatory in Adapt Pharma commercially launching their flagship nasal naloxone spray into US & Canada, and securing regulatory approval in Europe.
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He has extensive experience as QP releasing Advanced Therapeutic Medicinal Products (ATMPs), chemotherapeutics in a compounding pharmacy, and phase 1a monoclonal antibodies.
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Will has extensive experience as RP and controlled drug officer with responsibility for wholesale distribution of over $1billion worth of controlled drugs.
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Will has an MBA from Warwick University, a Masters in Industrial Pharmaceutical Science from the Royal College of Surgeons Dublin, a Masters in Biological Science from Dublin City University, and a B.Sc. in Biology from Maynooth University, Ireland.
A Qualified Person, also called a QP, is a highly trained pharmaceutical professional referred to in European law that meets the legal definition to be a QP.
They are personally named on an EU authorization to allow for the issuance of either a commercial or a clinical QP batch certificate.
The QP is the nominated individual in a pharmaceutical company that has the authorization to certify batches of clinical and/or commercial batches of medicine to markets for consumption.
They also must maintain oversight of the production process, quality control, and the quality system used to produce the products.
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Qualified Person (QP) Requirements:
The individual is trained as an industrial pharmacist, a dispensing pharmacist, or equivalent.
They must also satisfy the educational requirements as defined in the EU Regulations 536/2014, 2019/6, and the EU Directive 2001/83/EC.
A QP is required to maintain a program of continuous professional development performed annually.
Qualified Person (QP) Variants:
Human QPs
Veterinary QPs
Clinical QPs
Commercial QPs
QPs for pharmacovigilance (QPPV)
QP Certification and Oversight
QPs are required by pharmaceuticals companies within the EU to certify product to the market or clinical trials, as applicable.
The QP certifies batches of finished drug product for use in a clinical trial, for export, or before release to the market for sale.
It is a legal requirement to always have at least one (1) qp available for a manufacturer.
The QP is required to maintain oversight of the product, its production process, quality control, and distribution.
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QP Regulatory Support and Declarations
EU QPs shall also aid the regulatory function in applications and variations for the product by issuing a QP declaration on behalf of the company.
The QP declaration is a formal document that confirms manufacturers and test laboratories based outside the EU are working to an EU GMP standard and are hence equivalent to EU manufacturers/test laboratories.
This assessment is based on audits of these operations, as well as other factors, and can only be issued for a QP on the license for the product.
Talk to us today about QP audits of your supply chain.
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.