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www.sharpservices.com
Sharp Packaging Services
www.sharpservices.com: Sharp Clinical Services
About UDG Healthcare plcAn International Healthcare Services Organization
www.sharpservices.com: Sharp Clinical Services
UDG Healthcare plc
Founded in 1948
52 operating companies
FTSE 250 listed public company
€2.30 billion revenues in 2015
> €1.85 billion market capitalisation
www.sharpservices.com: Sharp Clinical Services
UDG Healthcare Plc
UDG Healthcare employs more than 7,000 people across 20 countries…
www.sharpservices.com: Sharp Clinical Services
- Medical information & Pharmacovigilance
- Sales channel solutions- Medical Communications- Patient support- Event Management
- Contract packaging solutions
- Serialisation services- Formulation Development- Analytical services- Label Design/Printing- Storage/Distribution- IRT Services- Regulatory Guidance
- Specialist healthcare & scientific products & services
- Outsourced sales & marketing
- Distribution & Engineering
UDG Healthcare Plc
www.sharpservices.com: Sharp Clinical Services
Sharp Packaging Services
www.sharpservices.com: Sharp Clinical Services8
Sharp Packaging Services
Overview – Provide international commercial & clinical packaging and
supply chain services to the pharmaceutical industry– 1,400 employees
Facilities in- United States
• Allentown, PA• Conshohocken, PA• Phoenixville, PA
- Europe• Crickhowell, UK• Hamont-Achel, Belgium• Heerenveen & Oudehaske, Netherlands
www.sharpservices.com: Sharp Clinical Services
Sharp Packaging Services
United KingdomUnited States
BelgiumNetherlands
United States
www.sharpservices.com
Sharp Packaging Solutions
www.sharpservices.com: Sharp Clinical Services
Packaging Capabilities
www.sharpservices.com: Sharp Clinical Services12
Multi-vac & Koch tray forming
Tyvek and film lidding
Multiple-component drug/device
combinations
- Vials
- Needles
- Needle connector
- Swabs
Specialised cartons
Kitting
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Packaging & Graphic Design
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Sharp Clinical Services
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End-to-End IntegratedClinical Supply Services
www.sharpservices.com: Sharp Clinical Services
SHARP CLINICAL SERVICES: UK
Crickhowell, Wales, UK — 14 Production Suites
(Primary/Secondary)— Commercial production suite— Controlled drug storage— Warehouse— Cold storage
3 QPs’ on Sharp UK LicenseValidated SAP system
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SITE LICENSES: UK
MHRA— Manufacturer’s MIA 10284 Importers License— Manufacturer’s Authorization (Investigational Medicinal
Products) MIA (IMP) 10284 — Manufacturer’s “Specials” License MS/10284— Wholesale Distribution License WL/10284— Home Office Controlled Drugs License (schedule II to V)
ISO accreditation— 9001 – commercial packaging— 13485 – medical devices
www.sharpservices.com: Sharp Clinical Services
SHARP CLINICAL SERVICES: US
Phoenixville— 26 Production Suites
(Primary/Secondary)— Warehouse
DEA Licensed for Controlled Substances (I-V)Analytical & formulation developmentFDA Registered SiteValidated SAP system
www.sharpservices.com: Sharp Clinical Services
SITE LICENSES: US
FDA Audited
DEA Registered—Analytical—Manufacturer—Distributer—Importer—Exporter
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Formulation Development & Analytical Services
www.sharpservices.com: Sharp Clinical Services
ANALYTICAL SERVICES
Seven Analytical Laboratories— Spectroscopy— Dissolution — Chromatography — Physical Testing — Sample Preparation — Development— Stability Storage Suite
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ANALYTICAL SERVICES
Analytical Laboratory TestingTechniques
— HPLC (ID testing, assay, impurity)— GC (OVIs, assay,
extractables/leachables)— UV-Vis Spectroscopy (ID, assay)— FTIR (ID, characterization)— Performance Testing (Friability,
Hardness, Dissolution Testing)— TOC (cleaning verification)— Classical (pH, KF, MP)
Studies— Competitor Analysis for Unbiased De-
Formulation— Dissolution Profiling— Accelerated Drug Stressing— Hygroscopicity Studies— Method Development — Process Development Support— Reference Standard Qualification
Testing— Stability (ICH and Custom)
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ANALYTICAL SERVICES
Stability Laboratory Testing
Stability and Storage TestingStability Study Protocol Design (ICH and Custom)Mapped Environmental Chambers Including:
— 25°C/60% RH— 30°C/65% RH— 40°C/75% RH— 25°C/20% RH — 25°C/30% RH / 5°C / Photo Stability
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FORMULATION DEVELOPMENT
Fluid Bed Granulation
Wurster Particle Coating
High Shear Granulation
Dry Blending
Dry Powder Filling (pouches and bottles)
Aqueous Film Coating
API direct filling
Capsule FillingPowders
Beads
Pellets
Liquids
Over EncapsulationTablets
Capsules
Tablet Compression
Solution and Suspension Processing
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FORMULATION DEVELOPMENT
Pre-Formulation ServicesExcipient CompatibilityPackage CompatibilityAPI Physical CharacterizationAPI Chemical CharacterizationAccelerated Degradation Prototype EvaluationsReverse Engineering
Formulation DevelopmentClinical trial materialsComparator blinding studiesMatching placebo developmentDevelopment of controlled release productsDevelopment of solid oral dose forms, semisolid and liquid products
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Manufacturing, Packaging & Labelling
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CLINICAL MANUFACTURING
Clinical Manufacturing Capabilities
Wet or Dry Granulation and Blending
Tablet Compression and Coating
Global Comparator Procurement
Manufacture Clinical Supplies
Blending and Encapsulation
Encapsulation and Over-Encapsulation
Phase I-IV Development and Reformulations
Placebo Manufacturing
Comparator Blinding
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CLINICAL MANUFACTURING
Dosage Forms TypesTabletsCapsules PowdersLiquidsSuspensionsSemisolids
Manufacturing CapabilitiesWet granulating and Dry BlendingTablet Compression and CoatingEncapsulationOver-EncapsulationPlacebo Manufacturing
www.sharpservices.com: Sharp Clinical Services
CLINICAL PACKAGING
Primary and Secondary Packaging Capabilities
Bottling (Solids / Semi-Solids)
Blister Packaging – Any Configuration— Coldform & Thermoform
Blister Card Sealing and Walleting
Pouching / Powder Filling
Label Application and Kit Assembly
Controlled Substance Packaging (Schedule I – V)
Ambient, Controlled Temperature, Refrigerated & Frozen Packaging
Blinding of canisters/syringes/vials/ampoules
Tube Filling
— Creams— Ointments
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OVER-ENCAPSULATION: SPEED & SCALE
MG PLANETAAutomated encapsulation and over encapsulation machine
Rate: Up to 50,000 capsules per hour
Capsule size: 000 to 5 (0, 00, DB-A, DB-AA)
Range: powder/pellets, tablets, capsules
Single/multiple dose capsules
100% verification of each capsule
Universal tablet feeder
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CLINICAL LABEL DESIGN & PRINT
Clinical Label Design & Print
Single & Multi-Panel Labels & Booklets
Single & Multi-Lingual
Randomized & Open
Regulatory and Translation Services
Sequentially Numbered
Variable Text
In house auxiliary variable data printing for outsourced booklet labels
32 Languages Fully Supported
Code Break & Randomization Generation
Client-Supplied Randomization Fully Supported
Annex 13 compliant & 21 CFR Part 11 Compliant PRISYM Software for Label Design
Cold room labelling
2D Barcoding capabilities
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Comparator / Ancillary Supplies Sourcing
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COMPARATOR SOURCING
Experienced comparator and rescue medication sourcing including:- Shelf-life management- Cost effective procurement- Country specific formulations
Approved vendors from local pharmacist to global sourcing located in EU, North America and SwitzerlandMHRA Wholesaler Distribution Licence
www.sharpservices.com: Sharp Clinical Services
QP Services
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QP SERVICES
SCS UK offers QP services in accordance with EU regulations that govern all IMP manufactured or imported by MIA IMP licence holders
SCS UK has three Qualified Persons (QP) with experience in the manufacture and supply of IMP
IMPD submissions; collation and review of all processes and documentation for regulatory approval
Audit of 3rd party manufacturing sites
QP declarations for use in submission of clinical trials application
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QP SERVICES CAPABILITIES
Audit of manufacturing sites within and outside the EU
Batch release certification
Auditing of the manufacturer’s quality system
Document and certification review of the manufacturer’s authorization to manufacture investigational medicinal products or comparators for export
Regulatory requirements for marketing authorization, GMP standards and any official verification of GMP compliance
Physical examination of packaging
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Project Management
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PROJECT MANAGEMENT
Customized communication plan
Planning & kick-off meetings
Business review meetings
Proactive innovation
Transparent communication & responsiveness
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PROJECT MANAGEMENT
Measuring Success— Overall Performance— On-time Production / shipmentsDedicated Project Management — Globally and Site Specific (Sharp Locations)— Cross functional teamsLessons Learned— Review of Goals Reached & Attempted — Review of Metrics in Reaching Goals - Performance— Evaluation of Communication
www.sharpservices.com: Sharp Clinical Services
Global Logistics & Supply Chain Management
www.sharpservices.com: Sharp Clinical Services
DISTRIBUTION CAPABILITIES
Shipment integration with internal and external IRT vendorsSharp Clinical Services SAP Portal Capabilities with ability to view:- Drug inventory/expiry updates- Shipment updates via Fed Ex, World Courier, UPS
Storage and Distribution direct from Sharp facilities and via GDP audited partiesControlled temperature shipments
(15 to 25°C, 2 to 8°C, -20°C, -70°C and -80°C)Shipment temperature monitoring and data retrieval of transit conditions
www.sharpservices.com: Sharp Clinical Services
DISTRIBUTION
Regional and global distribution capabilities include:- Direct to sites- Direct to customers- Bulk dispatches to 3rd party depots- On demand labelling and release- IRT and manual shipment request- Courier strategies
www.sharpservices.com: Sharp Clinical Services
GLOBAL FOOTPRINT: 30 Depots
AMERICAS:USAArgentinaBrazilChileColombiaMexicoPeru
ASIAPAC:AustraliaChinaIndiaHong KongJapanMalaysiaPhilippinesSingaporeSouth KoreaTaiwanThailandVietnam
EMEA:GeorgiaBelarusSerbiaTurkeyRussiaUkraineIsraelUKLebanonSouth Africa
www.sharpservices.com: Sharp Clinical Services
GLOBAL LOGISTICS & SUPPLY CHAIN MANAGEMENT
Customized Logistics Solutions
Import / Export of Clinical Trial Material
Depot Management
Conditions Supported:
Ambient
Refrigerated (2-8˚C)
Frozen (-20˚C, -70˚C, -80˚C)
Global Distribution Management
Specialized Logistics Project Management
Controlled Substance Management
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RETURNS & DESTRUCTION
Global retrieval of clinical site returns
Customer and Project Specific Returns and Reconciliation
Protocols
Dedicated returns storage area
Regulatory Compliance and Documentation Support
Updated and Complete Documentation on Destruction
Project close out
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Interactive Response Technology(IRT)
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IRT SERVICES
Sharp IRT Services Sharp IRT offers a more streamlined and successful means of managing your clinical supply chain.
Primary Benefits— 24 Hours a Day / 7 Days a
Week— Streamlined Setup and
Validation of New Studies — Accelerated Process for Moving
from Protocol to User Acceptance Testing (UAT)
— Extensive Experience and Guidance
— Utilizes Statistical Scheme— Balance at Any Level— Accommodates Stratifications
Access via Phone/Web— User Friendly and Easy to
Use— Data Entry Direct from
Source— Toll-Free Phone Lines— Secure Entry— Available 24/7— Multilingual
www.sharpservices.com: Sharp Clinical Services
IRT CAPABILITIES
Customized IRT system programmingPatient enrollment and randomization
Patient diaries
Site administration and tracking
Secure web-enabled reports
Clinical supply management including
automated supply and re-supply, site and
depot inventories, individual kit status and
activation notification, and expiry
management
Real-time reporting and tracking via web
Outbound fax and emails
Technical support and training for staff and
investigators
Adaptive trials
Predictive inventory
Supports multilingual voice recordings in an
unlimited number of languages
www.sharpservices.com: Sharp Clinical Services
IRT CAPABILITIES
Industry leading IRT ServicesWorld-class speed for setup and validation of new studies – less
than four weeks from User Requirement Specification (URS) approvals to User Acceptance Testing (UAT)
Minimizes Per-Patient Cost of TrialRapid Scale Out for New Sites, Dial-In Locations (Point of
Presence)Easy to Validate, Easy to Purchase, and Easy to ModifyEase of Access to Study MetricsExtremely FlexiblePrevents Drug WastagePrevents Patient Over-Enrollment
www.sharpservices.com: Sharp Clinical Services
IRT FLOW
Sharp WarehouseSharp IRT
Shipment Generated Orders
Processed, Confirmed, &
Shipped
Global IRT System Servers
Delivery to Sites
www.sharpservices.com: Sharp Clinical Services
Why Sharp Clinical Services?
www.sharpservices.com: Sharp Clinical Services
SHARP – SEAMLESS SERVICES DELIVERY
• Sharp provides end-to-end clinical supply services ‘under one roof’• Our IRT system is fully integrated with our SAP system – offering complete end-to-end
inventory management
IRTProduction
Storage
Shipment requests automatically sent to SAP
Global Sites
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End-to-End IntegratedClinical Supply Services