PCI Pharma Services Clinical Trial Services

PCI is committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively. Our clients come to us seeking solutions to often complex and unique opportunities due to our reputation for offering unmatched flexibility, a client-centric experience and consultative approach. We deliver a seamless clinical service including pharmaceutical development, clinical manufacturing, labeling, storage and distribution. Through our facilities located in North America, Europe and Asia Pacific, PCI provides a global service with localized focus, delivering over 200 protocols a year in over 100 countries, utilizing best-in-class technologies combined with our experienced and dedicated teams.

Together, delivering life changing therapies.

Your world leading CDMO.

Clinical Trial Services.

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Our Purpose Together, delivering life changing therapies.

Our Vision As a world class CDMO, we relentlessly strive to deliver better health outcomes for the patients we serve by combining our experience and expertise in science, manufacturing, and technology with our pristine customer service.

Our Commitment to Partnership and Quality We are regarded as being a true pharmaceutical and biopharmaceutical partner by our global customer base, delivering a flexible approach and seamless execution from the earliest stages of development through to commercial launch and beyond. Everything that we do is underpinned by a quality framework, incorporating expertise and innovation to ensure regulatory compliance and complete peace of mind.

Together, delivering life changing therapies.

Clinical Trial Services at PCI Pharma Services

Cold Chain Packaging and Labeling Expertise With global Cold Chain and Ultra Cold Chain capabilities, PCI can offer GMP

packaging, labeling, storage and distribution at a range of temperatures including: • 15˚C – 25˚C Controlled room temperature (CRT)

PCI is committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively.

Our clients come to us seeking solutions to often complex and unique opportunities due to our reputation for offering unmatched flexibility, a client-centric experience and consultative approach. We deliver a seamless clinical service including pharmaceutical development, clinical manufacturing, labeling, storage and distribution. Through our facilities located in North America, Europe and Asia Pacific, PCI provides a global service with localized focus, delivering over 200 protocols a year in over 100 countries, utilizing best-in-class technologies combined with our experienced and dedicated teams.

• 2-8˚C

• -20˚C

• -40˚C

• -80˚C

• -196˚C

Together, delivering life changing therapies.

Pharmaceutical Development

Supported Dosage Forms

Our comprehensive service offering includes early-stage formulation and analytical development for both highly potent and non-potent solid oral drug products as well as injectable therapies. We can offer API directly into capsules and vials using micro- dosing technology as well as the more traditional development pathways. The use of micro-dosing Drug in Capsule (DIC) and Drug in Vial (DIV) approach offers both time and cost efficiencies as well as the potential to reduce wastage of often expensive APIs. Following early-stage development, we continue with further development, scale-up and process validation ahead of commercial launch for a variety of dosage forms, all supported by full in-house analytical development and release services.

We can offer formulation development services for a variety of dosage forms including:

• Tablets, capsules and powders

• Gels and creams

• Oral liquids, solutions, suspensions and emulsions

• Suppositories and pessaries

• Granules for reconstitution

• Drug in capsule/vial

• Biologically derived and parenteral products

Together, delivering life changing therapies.

Clinical Trial Manufacturing

Micro-Dosing Xcelodose ® Technology

Delivering drug directly into capsules or vials using micro-dosing technology removes the need for initial formulation development and associated stability, leading to faster first-in-human studies and ultimately both time and cost efficiencies. The fully programmable system ensures exceptional levels of accuracy and precision whilst minimizing wastage of drug substance. We are proud to offer multiple options of micro-dosing technology, delivering individual client volume requirements. PCI has further invested in Xcelohood™ and Xceloprotect™ technology for the micro-dosing technologies, further enhancing our contained solutions for the development and manufacturing of highly potent drug products.

PCI provides a comprehensive service at each stage of the product lifecycle for a wide range of dosage forms in full compliance with GMP regulatory standards for both highly potent, non-potent and injectable drug products. Our strength lies in the integrated nature of our services, combining formulation and analytical development with GMP clinical manufacturing and packaging, managed by a full cross functional project team, coordinated by an experienced team of project managers. Utilizing our state-of-the-art facilities, we offer unrivaled capabilities and a true focus on customer needs. We provide clinical manufacturing of multiple dosage forms for investigational use including solid oral dose, liquids, semi-solids and aseptic fill finish processing. All clinical manufacturing and packaging services are fully supported by a dedicated and experienced team of Qualified Persons, a full analytical laboratory and a GMP compliant warehouse.

Together, delivering life changing therapies.

PCI Pharma Services

We blend extensive label design technology with flexible primary and secondary packaging suites to provide scalable packaging solutions for all phases of the clinical lifecycle. Our best-in-class packaging design team work with clients to optimize packaging design solutions for precise assembly and release of patient kits for global studies. The same in-house packaging development and design team will also work with you early in the clinical phases to develop a commercially viable packaging solution, delivering time and cost efficiencies as you move towards commercialization. Compliance and Adherence packaging can play an effective role in maximizing patient compliance and adherence by addressing core challenges through the integration of support tools combined with insightful and multifaceted solutions. Our innovative design and development services customize packaging solutions that optimize the interaction of the patient and the product. Clinical Trial Packaging and Labeling With unrivaled experience in packaging and labeling, we combine knowledge, expertise, innovative technologies and a dedicated team of specialists to ensure the highest quality standard of clinical supplies. We can accommodate product needs for light and oxygen sensitivity combined with temperature controls supporting Cold Chain and low-humidity conditions with technological solutions, regardless of packaging type or scale.

Cold Chain Packaging and Labeling Expertise

Our Global Clinical Trial Services include • Pharmaceutical development and clinical trial manufacture including highly potent drug products • Pharmaceutical development and clinical trial manufacture of biologically derived and parenteral products • Pharmaceutical development and clinical trial manufacture of Controlled Drug products • Packaging development and design services • Primary and secondary packaging • Advanced drug delivery and specialist injectable packaging • Final assembly of drug device combination products

PCI is a market leader in the provision of Cold Chain management. We provide specialist expertise in the packaging, labeling, storage and distribution of temperature sensitive clinical supplies including biologically derived and parenteral products. Utilizing state-of-the-art, validated cold plate and dry ice systems, PCI provides innovative solutions at a range of temperatures from controlled room temperature (CRT) (15˚C – 25˚C), through 2-8˚C, -20˚C, -40˚C, -80˚C to -196˚C ensuring product integrity and minimizing temperature excursions. We pride ourselves on our flexibility and where a special requirement is needed, partner with clients to create a bespoke offering at customer specific temperatures. PCI offers split-site Cold Chain storage providing additional security and risk management for client samples.

• Clinical supplies management • Clinical planning and support • Project management • IVRS-IWRS • Qualified Persons (QPs) • Support services • pci | bridge TM delivering real-time data management

Together, delivering life changing therapies.

Our scalable technologies deliver an output range from 3 units per minute to 300 units per minute. This unique offering enables us to manage dynamic client volumes of biopharmaceutical therapies and ultra orphan, niche personalized medicines to large-volume treatments and from clinical development through to commercial launch. Patient-centricity is key during clinical development stages, aiding ease of administration, adherence to therapies and ultimately improving clinical outcomes. At PCI we have over 20 years of experience specialist packaging of advanced drug delivery specialist injectable dosage forms. This combined with industry- leading capabilities in the final assembly, packing and testing of drug device combination products delivers a seamless solution for our global client base. Proving these expert services from early-stage development through to commercial scale launch, we support you at every stage of the product lifecycle and ultimately deliver true speed to market. Advanced Drug Delivery and Drug Device Combination Products

speed to study ™ As pharmaceutical companies seek to streamline early phase development to establish proof of concept quickly and efficiently, PCI’s speed to study TM services are designed to maneuver complex trial designs with maximized flexibility and speed. PCI has invested in global teams, sites and resources to provide time-tested, phase-specific processes, operations and the experts needed to deliver efficiently and cost-effectively. A culture of speed, expertise and flexibility is key to ensuring that early phase studies are initiated without delay and correctly from the start. PCI offers speed to study TM , a service combining an experienced team of manufacturing, packaging, labeling and global distribution specialists with expertise in early phase studies delivering maximum efficiency.

Together, delivering life changing therapies.

PCI Pharma Services

Global Storage, Distribution and Returns Services

Secure Storage

Biologics Leveraging over 20 years of experience in injectable packaging, PCI supports multiple delivery forms from Phase I through commercialization. Innovation in device assembly and our expanded capacity enables PCI to offer multiple options and speed-to-market. Our global clinical packaging capabilities for biologically derived products include:

PCI has the facilities to store and ship both controlled and dangerous goods throughout the world.

PCI offers over 30 years’ experience in the storage and distribution of clinical trial materials, effectively storing and distributing thousands of patient kits to over 100 countries.

Returns Management In keeping with client requirements, we can arrange for the return, storage and ultimate destruction of clinical trials materials at the end of a project.

At PCI we work with clients to develop a flexible and dedicated service to meet the needs of each and every clinical trial, irrespective of size or global requirements. Dedicated teams of logistics experts will ensure complete accountability and supply chain integrity throughout the clinical lifecycle. Clinical supplies are stored in facilities dedicated to investigational medicines meeting GMP requirements combined with a full collection, storage, returns and reconciliation of patient supplies ahead of ultimate client requested destruction.

• Vials

• Prefilled syringe assembly

Returns can be reconciled to one of three levels:

• Safety device assembly

• Level 1 – reconciliation of the number of shippers returned only • Level 2 – reconciliation of the contents of the shippers against a packing list • Level 3 – full reconciliation down to individual tablets, capsules, and vials

• Autoinjector assembly – multiple platforms

• Precise labeling

• Dividella top load cartoning

• Side load cartoning

• Cold storage

Together, delivering life changing therapies.

Analytical Services

Packaging Design and Development

Package Design and Development Overview

PCI’s pharmaceutical packaging design department provides an innovative and value-added service. Our dedicated team of in-house design specialists deliver insightful packaging design and practical knowledge to deliver differentiated and cost- effective packaging solutions. Using three-dimensional modelling, we can facilitate rapid prototype design and an expedited response to enable speed-to-market.

Design Conceptualization • Creative package design

PCI offers in-house laboratories providing a range of analytical services to support clients in the development, clinical and commercial supply of medicines globally. Our analytical services support a wide range of product types. Our state-of-the-art analytical facilities feature best-in-class, fully GMP and ICH compliant equipment enabling our teams to perform ID testing and analytical method transfers, through method development and validation, to global product release and ongoing stability testing ensuring regulatory compliance. Our facilities also include HEPA filtered air handling systems for the analysis of cytotoxic, teratogenic and uncharacterized products, a darkroom for the analysis of light sensitive products, and the capabilities to work with Schedule II-IV controlled substances.

• Consultative approach for collaborative design • Insights into potential challenges including Child Resistance, Senior Friendly, adherence and product administration

Rapid Prototyping • 2D and 3D CAD design • Graphic development • Photo realistic package rendering

Sample Creation • Physical demonstration through commercial grade prototypes

Proof of Concept • Child Resistant/Senior Friendly testing • Market research

• Human factor studies • Performance testing

PCI Pharma Services

QP Services Delivering Global Regulatory Requirements

With an unparalleled regulatory history, we provide QP Services through our team of Qualified Persons (QPs) who play a vital role in bringing your new products to market. Our highly experienced team ensures that clinical studies not only meet the most vigorous standards but also run smoothly, seamlessly and cost- efficiently. Our team of qualified persons assume responsibility for all stages of the process, safeguarding patients including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials. At PCI, our QPs also offer a consultancy service to ensure that operations are in-line with all relevant EU directives and other necessary regulations.

Our consultative and flexible approach combined with expertise ensures optimization of clinical trial costs and efficiencies.

• Dedicated Project Management

• pci | bridge TM

• Interactive Response Technologies (IRT)

• Comparator Sourcing

• Distribution and Logistics Planning

• Language Translation

• Multi-language Labeling

• Randomization

Together, delivering life changing therapies.

Support Services

PCI offers the expertise to assist clients with overcoming hurdles experienced during the clinical lifecycle, with a collaborative approach to solving challenges that may arise. At PCI, our mission is to offer the industry’s leading customer experience. This dedication is championed by our highly motivated and professional project management teams across North America, Europe and Asia Pacific.

Our teams work with clients on all aspects of their projects, leading to successful outcomes and ensuring client satisfaction. Project Managers are involved at the earliest stages of project development, providing insights and experience to guide projects and optimize critical timelines.

Additional Support Services

Choose PCI and benefit from the power of pci | bridge TM with: • Real-time data access and insights • Digitized workflows • Enhanced project management tools and tracking • Customizable reports • Secured environment (cyber security)

Our digital customer platform is designed to provide you with real-time insights into your portfolio of work at our sites around the globe. Now in its fourth year, through client feedback and our digital transformation strategy, we continue to develop the platform and deliver multiple feature releases, providing a best- in-class platform through the power of experience. pci | bridge TM delivers an industry-leading customer experience, unlocking your productivity with access to real-time supply chain information and digital workflows. Developed to complement customer service and project management capabilities, pci | bridge TM creates efficient and uncomplicated ways of working together. As a PCI customer, experience easy accessibility to production and distribution status, open invoicing and inventory information, documentation approvals and easy reporting features right at your fingertips.

• Language translation PCI provides efficient translation services with a guarantee of accuracy accompanied by a certificate of compliance with country specific regulatory requirements. • Multi-language labeling PCI provides a professional label design service for both single panel and multi-language booklet labels including solutions for Cold Chain refrigerated and frozen supplies. • Randomization PCI works with clients to develop randomizations as part of the initial trial planning and development. In addition, our flexible systems accommodate the importation of pre-prepared randomizations.

• Interactive Response Technologies (IRT) PCI is partnering with industry leader Suvoda to deliver a best-in-class seamless IRT system to our customers. Utilizing innovative technologies, system flexibility and creative design, the Suvoda solution ensures exceptional customer service. • Comparator Sourcing PCI is able to source comparator products, accompanied with the necessary documentation to ensure final release for the trial. • Distribution and logistics planning PCI offers a comprehensive global distribution plan using our in-house distribution facilities in combination with our strategic supply network. Our flexibility enables additional and specialized services including just-in-time (JIT) labeling or point-of-dispatch customization direct to patient.

Your world leading CDMO.

Let’s talk future ™

Together, delivering life changing therapies.

PCI Pharma Services

Other brochures in the series

Together, delivering life changing therapies.

Your world leading CDMO.

Advanced Drug Delivery and Drug Device Combination Products.

speed solutions ™

Drug Development & Manufacturing.

Commercial Packaging Technology.

pci.com

Advanced Drug Delivery and Drug Device Combination Products At PCI, we are experts in sterile fill- finish and lyophilization and the final assembly and specialist packaging of patient-centric autoinjectors, prefilled syringes and drug device combination product assembly, delivering end-to- end advanced drug delivery injectable solutions.

Drug Development & Manufacturing At PCI, we provide end-to-end clinical to commercial scale sterile fill-finish manufacturing, expertise in lyophilization, world class potent drug processing, and global launch experience.

Commercial Packaging Technology Commercial Packaging Technology With more than 50 years’ commercial packaging expertise combined with over 90 successful product launches each year, PCI is a global commercial packaging leader. Delivering design through commercialization and lifecycle management of all dosage forms through best-in-class packaging technology.

Accelerating your drug product from development to commercialization and beyond through complementary services, reducing supply chain complexity. Supporting you further with including: • & First Human Dose (FHD) • Quality and Regulatory Services (QRS) • Package Design and Development Services • New Product Introduction (NPI)

Your world leading CDMO.

Together, delivering life changing therapies.

DUBLIN, IRL

BURLINGTON, ON, CAN MISSISSAUGA, ON, CAN

MADISON, WI, USA ROCKFORD, IL, USA

HAY-ON-WYE, GBR TREDEGAR, GBR BRIDGEND, GBR

BEDFORD, NH, USA BOSTON, MA, USA

SAN DIEGO, CA, USA

BERLIN, DEU

LEÓN, ESP

MELBOURNE, AUS

PHILADELPHIA, PA, USA

NORTH AMERICA BEDFORD: +1 603 668 5763 | BOSTON: +1 508 545 6109 | BURLINGTON: +1 905 631 4476 | MADISON: +1 603 668 5763 MISSISSAUGA: +1 905 363 2100 | PHILADELPHIA: +1 215 613 3600 | ROCKFORD: +1 815 484 8900 | SAN DIEGO: +1 858 997 1490 EUROPE BERLIN: +49 (0)33 7013 6930 | BRIDGEND : +44 (0)1656 750550 DUBLIN: +353 (0)1 841 8300 HAY-ON-WYE: +44 (0)1497 820829 LEÓN: +34 987 107839 | TREDEGAR: +44 (0)1495 711222 ASIA PACIFIC MELBOURNE: +61 3 9673 1000

talkfuture@pci.com | pci.com

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