As a clinical QP authorization holder in Europe, we enable your human medicine imports, batch certification, and EU clinical trial launches
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You can trust us to provide the expertise and support your projects need to succeed
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Our virtual model ensures that we can deliver efficient and effective services without the need for manufacturing, QC, or warehousing/distribution activities.
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Outsource your clinical QP and auditing needs to Rexpharma to increase your EU compliance and reduce you departmental complexity.
Where Clinical Manufacturers/Sponsors wish to supply an EU clinical trial with IMP, each batch needs to have a QP batch certificate issued by an EU QP.
Rather than establishing a company in the EU, Manufacturers/Sponsors have the option of outsourcing this batch certification step to a specialist company such as Rexpharma.
QP Batch Certification of human IMP on behalf of third party Clients is the core service at Rexpharma.
Outsourcing with Rexpharma saves Clients the difficulty, expense, and challenge of:
Recruitment of local staff & payroll
Navigating the complexities of EU finance, HR, insurance, & tax laws
Acquiring an EU clinical authorisation for their QP function
Hosting periodic regulatory inspections by an EU competent authority
Rexpharma performs QP batch certification upon importation of the IMP into the EU and releases the batch on behalf of the Sponsor for onward supply to European clinical trials.
Rexpharma has an approved EU GMP operation established and ready to provide this fully outsourced service to Clients.
For your Clinical Trial Application (CTA) in the EU, your regulatory function will require an EU QP to issue a QP Declaration for the regulatory application.
This QP Declaration is document that outlines all non-EU manufacturers and quality control facilities have been assessed and found to be equivalent to EU facilities (from a GMP perspective).
It is key to work with your EU QP to ensure all audits are in place and acceptable to allow for QP Declaration issuance.
Regulatory services:
Regulatory Consultancy and professional opinion
Support on entering the EU
Regulatory issues & inspection support
Brexit
This QP Declaration is hence is critical quality document for your CTA and it’s based on audits, can take time to establish the grounds for issuance.
QP services:
QP Consultancy and professional opinion
Remedial projects
Audits are needed for quality compliance but also supply chains continually change and need rationalization. Whether is a new or an existing supplier, Rexpharma is here to support your business grow with our audits service.
Our Quality/QP Audits are performed by IRCA-qualified auditors in support of your company’s needs.
We can perform a wide range of audits such as:
Due Diligence Audits
For Cause Audits
Internal Audits
Mock Audits
Pre-Approval Audits
Pre-Licensing Audits
QP Audits
Supplier Audits
Our audits are carefully scoped with the Client to ensure the best result all round - see below for more detail.
We have broad expertise in manufacturing, quality control, and warehouse/distribution audits.
We can audit clinical (phase I-IV) and commercial facilities as follows:
In small-to-medium sized pharma operations, it can be efficient to outsource the quality function and associated quality management system. Quality as a Service (QaaS) is an activity best suited to a capable supplier and Rexpharmas highly experience management team that can be trusted to manage your quality function.
Our HPRA-inspected SOP templates are available as a bundle for purchase for your internal use to support clinical manfacturing at your site. Alternatively, we can appoint a quality director for your company that can issue a QMS for your operation, and manage it on your companies behalf to ensure complete compliance.
Business cases for when use of QaaS make most sense:
In start up enterprises that are still filling executive functions but have an aggresive launch timeline for their clincal protocol
Companies need acquiring a new regulatory authorisation often need a new quality system built from scratch and tailored to their operations.
Having significant experience in this area, we can design your quality system from scratch for a new license, or can overhaul an existing process to make it compliant with local EU regulations.
Core consultancy services are:
Advice on IMP and EU GMP compliance
Quality Management System (QMS) design
Product Specification File development
Comprehensive support from experienced QPs and quality professionals
Quality & QP Risk Assessment
GMP Training
Additionally, companies may require an overhaul of their existing quality system based on:
Inspection/Audit Observations
Gap analysis or risk assessment
Change from new products, new market launches, commercialization, and product development
Where GMP training is needed for staff and stakeholders, training programs shall be tailored to meet specific quality and compliance needs.
Rexpharma has significant experience developing and maintaining clinical and commercial package artworks.
Training needs may be:
Annual GMP Training/Refresher
ATMP Products
EU Regulations
Remediation projects
Packages may be:
Cartons
Product labels
Patient information leaflets
Inserts & tamper evident seals
Primary packaging material
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.