IMP Pharmaceutical Services is based in South Wales, UK, and specialises in clinical trial supply. The company holds MIA(IMP) and MS licences (ref: 96345) from the MHRA.
IMP Pharmaceutical Services was set up in 2015 by directors Dr Rachel Hopkins (Operations) and Dr Karl Fry (Quality). The first warehouse was planned and developed throughout the first half of 2016 alongside a quality management system that drew on the extensive pharmaceutical experience of both directors. The site received its initial MHRA inspection audit and the site MIA(IMP) licence was issued by the MHRA in October 2016.
Since then, we have added another warehouse and staff offices to accommodate our growing team of experienced and trainee members of our team. Our MIA(IMP) licence has been updated to cover the expanding scope of services offered and we have received two further routine GMP MHRA inspections (including one ‘desktop’/remote audit).
Qualified person support for early clinical trial stages
Qualified Person (QP) support will be essential at the planning stage of your clinical trial ‒ for example, you may need QP audits planned and booked, risk-based advice on your regulatory submissions, input into your IMPD or advice on early MHRA discussions. QP input will ensure there are minimal delays when issues such as expiry date extensions are required.
IMP Pharmaceutical Services’ project coordinator team will assist you with importation of your product to the UK or offer advice on domestic transport services if your product is manufactured in the UK. We ensure that you get ongoing access to QPs for advice and support at IMP Pharmaceutical Services. This access to the QP responsible for certifying product for your project is something that differentiates us from some larger service providers and feedback from clients confirms that this level of communication is beneficial and appreciated.
Our project coordinator team work closely with the QPs at IMP to schedule meetings or regular online calls should you need them. Our QP services extend to GB QP Oversight for clinical trial product that has been EU QP-released and requires the oversight for importation into GB clinical sites or for storage and distribution from IMP Pharmaceutical Services. Our QA team will support any requests for completion of questionnaires and onsite or remote audits of IMP to approve us within your quality systems.
Flexible warehouse facilities for clinical material storage
IMP Pharmaceutical Services’ warehouse facilities are flexible for storage capabilities. Each of our two warehouses is 100m2 with the capability to store investigational medicinal products, AxMPs, sundry items and packaging materials at: 15-25°C, 2-8°C, -20°C, -40°C and ULT (-80°C), temperature conditions are controlled and monitored, we can also monitor humidity if that is important for your products.
One of our warehouses is equipped with a Grade VIII walk-in vault suitable for storing controlled substances (licence-dependant). This warehouse also houses an ISO 6 qualified clean tent (self-contained positive pressure inflatable cleanroom with HEPA-filtered air supply and anteroom). The clean tent is currently being utilised for routine sampling of client excipient materials, and we would welcome the opportunity to develop this facility further to meet our customer’s requirements. We have also recently installed a walk-in cold room which is controlled and monitored at 2-8°C.
Your clinical trial supply set up will be driven by an IMP Project Coordinator with support for the QA team to ensure that documents are written and agreed in a timely manner. We will share the list of documents you need to provide in order to build the Product Specification File which ultimately allows the QP to certify finished product, this applies to both traditional UK clinical trials and the GB QP Oversight route.
Full-service support for clinical trial systems
IMP Pharmaceutical Services will work with your partners when you are developing and testing your IxRS or IRT system; alternatively, we can support you with manual orders if that is more suitable for your clinical trial supply. We will ensure that any necessary agreements are in place with our preferred couriers to support your clinical trial supply or we are happy to work with your preferred couriers using your account details.
We have supported direct-to-patient (DTP) clinical trial supply in the UK and have worked successfully with regulatory teams, sponsors and nursing teams to facilitate successful trials that support trial participants and delivery of product at the home addresses.
You will be supported throughout the duration of your clinical trial, we understand that things sometimes go wrong when the trial is happening in the real world however much you have risk assessed the trial design, product supply and team support prior to starting the trial.
We pride ourselves on being flexible and responsive to meet sponsor’s and or customer’s requirements as we know that deadlines need to be met for your clinical trial participants, your clinical partners such as your regulatory teams and your business needs.