Catalent
Contact Details
Name: Catalent Pharma Solutions
Address: Lancaster Way
Town: Westhoughton
City: Bolton
County: Greater Manchester England
Postcode: BL5 3XX
Phone: 01942 790000
Fax: 01942 799799
Website: https://www.catalent.com/
E-mail: info@catalent.com
Opening Times
Monday: 09:00 – 17:00
Tuesday: 09:00 – 17:00
Wednesday: 09:00 – 17:00
Thursday: 09:00 – 17:00
Friday: 09:00 – 17:00
Saturday: Closed
Sunday: Closed
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Catalent
About Catalent
Modern clinical supply solutions designed to meet the needs of sponsors and patients
At Catalent, we are keenly aware that every clinical sponsor and every study has different needs and challenges.
Which is why we offer you a choice of individual services, fully integrated solutions and innovative supply models such as our FastChain™ demand led supply solution to find the optimal approach that suits your needs. Our clinical supply experts work with you to identify and build a clinical supply strategy takes into consideration your study protocol, timeline, and budget.
As a global leader in clinical supply services, we have experience working with customers and clinical studies of all sizes from top global multinational pharma down to small and virtual companies.
Since our earliest days more than 25 years ago, we have reliably supplied thousands of studies in over 80 countries. We attract some of the best talent in the industry and the expertise contained within in our team is impressive.
Our employees are committed to driving service excellence and actively contributing to a “Patient First” culture that puts the patient at the centre of everything we do.
Catalent’s commitment to quality can be seen throughout our organization, from our inspection-ready sites to our efforts to continually refine and improve the type and scope of services we can provide our customers.
We pride ourselves on our ability to offer our customers clinical supply solutions that are innovative and flexible and support them in their pursuit of important and potentially life-changing and life-saving medications.
Catalent Services
Project & Clinical Supply Management
Complete, cost-effective support for your clinical trial
With more than 5,000 trials to date, we have the experience needed to optimize your study design and ensure cost-effective approaches for simple protocols to the most complex studies. Our experience with the international regulatory environment, demand simulation and forecasting, and practical issues drives reliable supply and minimizes waste.
Our unmatched capabilities in clinical supply management include:
- Global supply chain project lifecycle management, from manufacturing through final accountability and destruction
- Supply chain planning and optimization services including forecasting
- Coordination and collaboration with clinical, medical and third-party teams to develop and monitor the clinical supplies plan
- Integration with IRT (IVR/IWR) systems including co-development of requirements, specifications and monitoring
- Catalent Fusion suite and customer portal to enable secure document sharing, real-time shipment tracking, reporting and supply chain visibility
- Management of inventory levels and expiry data to monitor and control stock at clinical storage facilities, depots and clinical sites
- Consultative services for cold chain requirements and controlled substance management
Comparator Sourcing
Global Comparator Sourcing
Our service is what sets us apart
Our unmatched capabilities in comparator sourcing include:
- Direct comparator sourcing from innovators, major wholesalers and local distributors
- Central or local sourcing depending upon study needs
- Robust supply chain management and forecasting to optimize your sourcing strategy
- Strict adherence to storage requirements and specialty handling of cold chain, biologic, potent/cytotoxic and controlled drug substances
- Biologics and small molecule analytical services including release, equivalency and stability testing
- Clinical manufacturing services including blinding, over-encapsulation and masking
Blinding & Clinical Manufacturing
Clinical Manufacturing, Blinding, Over-encapsulation & Masking
Speed, Flexibility & Creativity
With a dynamic range of cutting-edge equipment and flexible capabilities, we can procure, blind and distribute virtually any drug product. Our packaging experts work with you to solve even your toughest blinding and clinical packaging challenges. When you need clinical manufacturing services, we offer easy transfers and fast scale-up to achieve the efficiency, speed and savings you demand.
Our blinding capabilities include:
- Syringe, vial and device masking
- Automated deblistering
- Fully automated over-encapsulation
Our clinical manufacturing capabilities include:
- Blending, granulation and encapsulation
- High-speed capsule manufacturing with 100% weight checking of all capsules
- Customized fills, including hard gelatine capsules
Primary Packaging
Speed & reliability where you need it
We’ve helped hundreds of companies of all sizes supply their clinical studies. From small scale Phase I studies to complex, large global Phase III studies, we can help you overcome project challenges and ensure you get the highest quality, most cost-effective solution. Our investments in automated equipment and specialty handling suites provide industry-leading efficiency, accuracy, capacity and flexibility to help speed your product to clinic.
We perform GMP primary packaging at our North American, UK, European and Asia Pacific facilities to supply your studies virtually anywhere in the world. Working in close collaboration with you, we develop solutions that are not only material efficient, but also meet your critical trial timelines.
Primary packaging services include:
- Automated, high-speed blistering & bottling lines
- Automated plunger-rod insertion & labelling for pre-filled syringes
- Semi-automated and hand-fill bottling lines for smaller batches
- Temperature & humidity controlled packaging suites
- Dedicated potent/cytotoxic packaging rooms/suites
- Oxygen & light sensitive packaging options
- Package engineering & patient kit design services
Low-volume Commercial Packaging
It can be challenging to obtain timely commercial packaging services for low-volume drugs such as niche and orphan products. We have the capacity, commercial serialization capabilities and extensive expertise managing complex supply chains to support your commercial packaging needs.
Secondary Packaging & Clinical Labelling
Safeguard Your Temperature Sensitive Products
Catalent offers GMP secondary packaging and clinical labelling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes.
For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.
Using our Clinicopia global labelling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Secondary packaging & clinical labelling services include:
- Automated wallet sealing
- Hand assembly
- Scan and assembly
- Cold room packaging
- Patient kit design services
- Label design & printing
- Multiple label types (single/booklet)
- Harmonized labelling system
- Global phrase library
- Online label review and approval
Package Engineering & Patient Kit Design Services
Our global team of package engineering experts work with you to solve tough primary and secondary clinical packaging challenges, prioritize your desired packaging attributes and functionality to develop a custom packaging solution or identify existing off-the-shelf options that meet your specific needs.
We work in collaboration with you to optimize your packaging solution according to the priorities you define such as cost, flexibility or the improvements to the patient experience. As your project progresses from concept to reality we can provide you with 3D digital renderings that you can turn and rotate with the click of a mouse, carton prototypes from our onsite, custom foam inserts to protect fragile syringes and vials, 3D printed blister card samples you can touch, and more.
Available storage environments & global distribution services:
- Clinical supply management services to inform optimal package configuration
- Primary package design, especially for blistering
- Senior-friendly and child-resistant options
- Secondary package/patient kit design
- Custom foam inserts to reduce risk of breakage
- Carton prototypes
- 3D renderings and printed samples
Global Distribution & Logistics
Complete & proven worldwide support for your
clinical supply chain strategy
We have GMP facilities in the US, UK, Germany and Asia-Pacific region, as well as a global network of 50+ strategically located depots across 6 continents. Whether you need regional support and expertise or require a global solution, you can depend on us to reliably supply your products worldwide.
Our logistics experts carefully consider your project dynamics to select the optimal mix of couriers and shipping lanes needed to maintain product integrity while balancing distribution speed and cost efficiency.
Safeguard Your Temperature Sensitive Products
Our customers rely on our industry-leading capacity and state-of-the-art monitoring systems used throughout our cold chain network. We offer a variety of cold shipper solutions including EPS/water, VIP and PCM systems and temperature monitoring devices. With our global end-to-end support capabilities and partnerships with industry-leading couriers, you can rest easy knowing your products are handled appropriately – all over the world.
Available storage environments & global distribution services:
- Ambient, CRT (15-25C), refrigerated (2-8C), frozen (-15 to -25C), ultra-low frozen (-40C to -60C, -70C to -90C and cryogenic)
- Controlled drug substance storage and distribution (DEA Schedule I-V)
- QP release services in UK & EU
- Integration with IRT and customer inventory management systems
- Variety of ambient and cold shipper solutions including EPS/water, VIP and PCM systems
- Global network of 50+ depots and industry-leading couriers
- Returns, reconciliation and destruction
Controlled Substances, Expert Guidance & Specialised Logistics
Our experienced teams have the extensive regulatory and logistical expertise necessary to help you navigate the challenges of distributing your controlled drug substance on a global scale.
Full Time Qualified Persons For UK and EU Study Support
Our clinical packaging facilities in England, Scotland and Germany have full time on-site Qualified Persons (QPs) experienced in multiple dosage forms, capable of confirming EU GMP compliance of your supply chain, in order to provide EU GMP declaration for 3rd country sites.
The QP’s will ensure products produced meet your regulatory commitments enabling them to provide QP certificates, supporting the release of your clinical supply batches for distribution within the EU and for export outside the EU. Our QPs use harmonized processes and documentation that supports the efficient release of your supplies irrespective of the EU facility supporting your trial.
Supply Chain Visibility At Your Fingertips
Ongoing testing and validation of our supply chain ensures that we provide our customers with the best logistics solutions available. Our electronic inventory management system through Catalent Fusion, allows you to actively monitor your materials from virtually anywhere.
Cold Chain Services
Worldwide cold chain expertise and capabilities for temperature sensitive products
Successful cold chain handling of temperature sensitive clinical supplies requires specialized services and expertise. From secondary packaging services to our full range of cold chain clinical storage environments and global distribution capabilities, and more we have the necessary expertise and worldwide services to safeguard the integrity of your cold chain product.
Cold chain services include:
- Cold Room Secondary Packaging and Labelling
- Packaging over dry ice for deep frozen products
- Packaging of zero time-out-of-environment products
- Label adhesion testing for frozen supplies
- Cold Clinical Storage (refrigerated, frozen, deep frozen & cryogenic)
- Multiple cold shipper options including EPS/water, VIP & PCM systems
- Global Cold Chain Distribution
- In-shipment Temperature Recording Devices
- Temperature excursion reporting
Clinical Returns, Reconciliation & Destruction
Keeping the end of your study in mind from the beginning
An often overlooked aspect of clinical supply management is planning for clinical returns. At Catalent, our clinical supply experts can help you develop a prudent clinical returns plan that takes into consideration any drug or country-specific challenges that may need special consideration. If desired, we can perform accountability down to the individual pill or dose level or examine returns to determine exactly how much product was used.
Services include:
- Clinical returns strategy planning
- Reconciliation & drug accountability
- Country-specific return logistics
- Clinical storage and pooling of returns for bulk destruction
- Destruction of returned materials
- Local/regional destruction and certification
- Retention documentation