www.bilcaregcs.

com

Global Clinical Supplies


Content
Summary 03
Overview 04
The Bilcare Advantage 05
Products and Services Overview 06
Formulation Development 08
Analytical & Research Services 09
Clinical Manufacturing Packaging & Labeling 10
Project Management Services 13
Global Logistics and Supply Chain Management 14
Interactive Voice/Web Response System 15
Facilities – Americas 16
Facilities – Europe 17
Facilities – Asia-Pacific 18
The clinical trial
landscape is changing
With the globalization of
clinical research, the entire drug
development process has grown
more complex. The increasing
size and complexity of clinical
trials presents the pharmaceutical
industry with several challenges.
Clinical development today takes
longer, and costs more.
Recent and ongoing changes
in the pharmaceutical and
biotechnology industries
dictate that companies find
greater R&D efficiencies by
streamlining operations and
focusing on core competencies.
3
Bilcare GCS (Global Clinical
Supplies) partners with customers
to provide Clinical Trial Materials
(CTM) services for swift clinical
development in the new
landscape. From pre-formulation
to returns and destruction
accountability, our integrated
offerings are aimed at establishing
your critical success factor –
speed-to-market.

4
Partnering with customers
to improve patient
healthcare outcomes
Bilcare GCS is a leading
global provider of Clinical
Trial Materials (CTM) services
to the pharmaceutical and
biotechnology industries.
Bilcare GCS is a business unit of
Bilcare Ltd. - an innovation-led
solutions provider that partners
with the global pharmaceutical
and healthcare industry to improve
patient healthcare outcomes.
We are committed to serving
our customers’ evolving drug
development needs. A single
trusted source – with the
Innovation
Technology
Flexibility Delivery beyond Knowledge
compliance
•Global capabilities with local service. •Project management •One-stop-shop for clinical supplies •State-of-the-art facilities and technologies
•Best-in-class project management •Contract management •Industry-leading experience and resources
•Seamless support •Integrated quality assurance •Integrated drug development services
•Quick turnaround •System integration
5
Value through
innovation
experience, resources, and Bilcare GCS’s breadth of
capabilities that cover the full knowledge is unique, but our real
spectrum of services across point of difference is the ability
the supply chain, from pre- to innovate and collaborate with
formulation to global logistics and customers and partners to solve
distribution, Bilcare GCS complex clinical trial challenges.
aims to transform the global
clinical trial lifecycle.
We aim to bring significant change
and innovation to the global drug
development continuum. With a
global commitment to innovation,
we are constantly creating new
and better technologies that
enhance your clinical trial process
and give you a competitive edge.
 BILCARE GCS GLOBAL CAPABILITIES AMERICAS EUROPE Asia-Pacific

Analytical & Research Services

• Analytical Laboratory ü ü ü1
• Release Testing ü ü ü2
• Stability ü ü2 ü2
• Method Development ü ü1 ü1
SERVICES • Cleaning Verification ü ü ü
• Controlled Substance Management ü ü1 ü1
In-Sourcing CTM Services Analytical & Research Services Global Logistics &
Formulation Development
Interactive Voice/Web • Controlled Substance Management ü ü1 ü1
Supply Chain
Response System Clinical Manufacturing, Clinical Manufacturing
QP Services Management
Packaging, & Labeling • Solid, Liquid, Creams ü ü ü1
• Encapsulation ü ü ü1
Formulation Development Depot Management Comparator Sourcing • Over-encapsulation ü ü ü1
• Controlled Substance Management ü ü ü1
Quality Foundation Packaging
• Bottling ü ü ü
• High Speed Bottling ü ü2 ü2
• Blistering ü ü ü
• High Speed Blistering ü ü ü1
• Pouching ü ü ü1
• Tube Filling ü ü ü1

End-to-end services for

• Blister Carding
6 ü ü ü
7
• Label Application and Kit Assembly ü ü ü
• Controlled Substance Management ü ü ü

your global clinical

• Comparator Sourcing & Acquisition ü ü ü
Labeling
• Label design ü ü ü
• Label production ü ü ü

supply needs
• Label procurement ü ü ü
Global Logistics & Distribution
• Cold Chain Shipping ü ü ü
• Ambient (15-25°C) ü ü ü
• Refrigerated (2-8°C) ü ü ü
• Frozen (-20°C) ü ü ü
With best-in-class manufacturing range of requirements from • Deep Freeze (-70°C/-80°C) ü ü ü
plants and facilities on three pre-formulation research and • Inventory Management ü ü ü
continents, Bilcare GCS delivers development, manufacturing, • Returns & Destruction ü ü ü
end-to-end solutions that support analytical services and clinical • Controlled Substance Management ü ü ü
a drug through the entire clinical supplies packaging and labeling IVRS / IWRS
trial life cycle. to IVRS, QP services, controlled- • Design ü ü1 ü1
Our services for solid, semi-solid, temperature (cold chain) CTM • Management ü ü1 ü1
liquid, DEA (CI-V), scheduled storage, worldwide distribution Comparator Sourcing
drug and biotech clinical trial and returns and destructions • Comparator Sourcing ü ü ü

materials (CTM) satisfy a broad accountability. • Comparator Distribution Mgmt ü ü ü

IN-Sourcing – Offsite Clinical Supplies Ops.
• Formulation Development ü
• Analytical & Research Services ü
• Clinical Manufacturing ü
• Packaging ü ü ü
• Labeling ü ü ü
• IVRS/IWRS ü
• Global Logistics & Distribution ü ü ü
• Quality Assurance Services ü ü ü
Quality Services
• QP Services ü1 ü ü1
• Regulatory Support ü ü ü
• Archiving Services ü
 - Fully Supported
 1 - Achieved with support from Bilcare GCS Americas and/or Europe / Bilcare approved third party
 2 - Achieved with support from Bilcare GCS Americas / Bilcare approved third party
8 9
Reliable formulations for
optimal clinical outcomes
With an experienced team
of formulation scientists
complimented by state-of-the-
art equipment and laboratory
facilities, Bilcare GCS offers
innovative formulation solutions
that operate in synergy with
your Active Pharmaceutical
Ingredient (API).
Pre-formulation
Bilcare GCS offers extensive pre-
formulation studies relevant
to establishing and advancing
optimal dosage forms.
• Physical properties
• Product characterization
• Chemical compatibility
and reactivity to packaging
substrates
• Accelerated degradation
• Excipient compatibility studies
Service and Quality beyond Compliance
Formulation Development
Bilcare GCS offers customized
formulation development services
to assist clients in identifying the
best form of delivery and the most
viable manufacturing strategy for
their API.
• Clinical supplies manufacturing
• Blending and encapsulation
• Over-encapsulation and
blinding
• Phase I-IV development and
reformulations
• Placebo manufacturing/
comparator supplies
• Developing both ethical and
over-the-counter products like
tablets (normal and controlled
release), powders, liquids,
suspensions, emulsions, creams
and ointments, lotions etc.
• Developing line extensions
Technical Services
Bilcare GCS provides a range of
technical support services to help
achieve your clinical trial goals
and troubleshoot or improve
existing products.
• Providing experienced
professionals to troubleshoot
commercial products
• Evaluating new raw materials
in existing products
• Overseeing transfer of products
from research to production
facilities
• Assessing current products and
recommending improvements
to modernize existing
manufacturing processes
Formulation Development
Quality analytical services
within your timelines
Bilcare GCS’ analytical and
research services evaluate the
performance of formulations
using various investigative
testing procedures, enabling
the foundation for
future developments.
Analytical & Research Services
Bilcare GCS’ comprehensive
offering of analytical
services for drugs, packaging
materials, components and
systems includes:
• HPLC analysis
• Content uniformity studies
• Chromatographic impurity
profiling
• Performance type testing
(e.g. friability, hardness and
dissolution testing)
• Identification testing
• Release testing
• Stability and storage testing
• Cleaning verification /
validation
• Accelerated drug stressing
• Dissolution profile testing
• Disintegration testing
• Extractable studies for
parenteral products
Service and Quality beyond Compliance
• Competitor analysis for
unbiased de-formulation
• Hygroscopicity studies
• Method development and
validation for all phases and
components in development
of drug substances, non-
compendial excipients and
drug products
• Process development support
• Reference standard
qualification testing
• Stability study protocol design
(ICH and custom)
• Mapped environmental
chambers including 25°C/60%
RH, 30°C/65% RH, 40°C/75%
RH, 25°C/40% RH, 40°C/25%
RH, 5°C, and photo stability
10
Best-in-class
manufacturing
Bilcare GCS offers comprehensive
clinical manufacturing, packaging
and labeling solutions to
maximize client investments,
minimize development time and
reduce overall costs.
Service and Quality beyond Compliance
Clinical Manufacturing
Bilcare GCS offers a wide range of
clinical manufacturing capabilities
to provide efficient and agile
manufacturing of solid dosage
forms as well as liquids, creams
and ointments.
Clinical Manufacturing Capabilities
• Wet or dry granulation
and blending
• Tablet compression
and coating
• Global comparator
procurement
• Manufacturing clinical supplies
• Blending and encapsulation
• Encapsulation and over-
encapsulation
• Phase I-IV development and
reformulations
• Placebo manufacturing
• Comparator blinding
Clinical Manufacturing
Clinical Packaging
Through comprehensive packaging
research, Bilcare GCS produces
customized and innovative clinical
packaging materials. Bilcare GCS
assists its clients in selecting
appropriate packaging solutions
through complete production
and delivery.
Packaging and Labeling
11
Innovative
packaging
Primary and Secondary Packaging • Packaging cost evaluation
• Bottling (solids / semi-solids) including indirect costs such as
• Blister packaging – any transportation and storage
configuration • Evaluation of packaging
-- Coldform & thermoform productivity based on process
• Blister card sealing and machine efficiency,
and walleting machine time utilization and
• Pouching / powder filling production waste
• Label application and • Compliance with cGMP
kit assembly standards as well as USA and
• Controlled substance packaging international regulations
(schedule I – V) and guidelines
• Ambient & controlled • Quality control and quality
temperature (refrigerated / assurance evaluations
frozen) packaging
• Tube filling
-- Creams
-- Ointments
Packaging Research and
Audit Services
• Evaluation of packaging efficacy
through physicochemical
requirements and actual field
performance
Service and Quality beyond Compliance
12
Innovative
packaging
Clinical Labeling
Bilcare GCS provides full labeling
services for your product in
line with global regulatory
requirements.
• In-house label design and
production
• Types of labels
-- Single & multi-panel
-- Single & multi-lingual
-- Randomized & open
-- Sequentially numbered
-- Variable text
• Full support for languages
• Code break & randomization
generation
• Client-supplied randomization
fully supported
• 21 CFR Part 11 compliant
PRISYM software for importing
randomisation schedules, label
design and printing
• Booklet label production
Service and Quality beyond Compliance Packaging and Labeling
13
End-to-end Project
Management
Our unique approach to project Communication Dedicated Project
management includes the • Customized Management
generation of a concise and agreed Communication Plan • Globally and site specific
upon Integrated Project Plan • Kick-off meetings (Bilcare locations)
complete with full visibility. • Team meetings • Label control teams
This effectively communicates the • Logistics teams
project scope, resources and cost Measuring Success • Regulatory Support and
with the added ability of being • Overall performance, quality Archiving Services
able to identify issues and assess and accuracy
risks that may threaten the critical • On-time production Lessons Learned
path of a project. • On-time shipments • Review of goals reached &
and logistics attempted
• Processing of import/export • Review of metrics in reaching
materials and supplies goals -performance
• Evaluation of Bilcare locations in • Evaluation of communication
general and specific functions
• Gantt charts
Project Management Services Service and Quality beyond Compliance
14
Reliable supply chain
management and logistics
Bilcare GCS provides you with the
unique capability of a real-time
distribution process using a simple
and effective local management
model. Bilcare GCS’ global logistics
and supply chain management
solutions optimize logistics under
a wide array of conditions and
overcome inefficiencies whilst
complying with regulatory standards
for your clinical supply chain.
Service and Quality beyond Compliance
End-to-End Supply Chain
Solutions
• 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)
• Cold chain solutions
• Qualified Person (QP) supply chain
declaration and importation and
batch release of IMP
• Global distribution
management
• Specialized logistics project
management
• Integrated IVR system
inventory/tracking
Global Logistics and Supply Chain Management
Returns and Destruction
• Customer and project-specific
returns and reconciliation
protocols
• Secured storage
• Regulatory compliance and
documentation support
• Updated and complete
documentation on destruction
Controlled Substance
Management
Bilcare GCS is registered with
the DEA and the Government
of UK as a manufacturer,
distributor, exporter, importer and
analytical laboratory of controlled
substances.
Bilcare GCS’ IVR/IWR system is
fully customizable and flexible
to ensure that all your clinical
trial needs are met without
interruptions. Bilcare GCS’ IVR/
IWR system is 21 CFR Part 11
compliant and ensures data
integrity, acceleration of clinical
site initiations and provision of
real-time patient, site and study
metrics via an interactive website.
Interactive Voice/Web Response System (IVR/IWR)
15
The Bilcare
IVRS/IWRS edge
Services • Real-time reporting and
• Customized IVR/IWR system tracking via web
programming • Technical support and training
• Patient enrolment and for staff and investigators
randomization • Outbound fax and emails
• Patient diaries • Adaptive trials
• Site administration and tracking • Predictive inventory
• Clinical supply management
including automated supply
and re-supply, site and depot
inventories, individual kit status
and activation notification, and
expiry management
• Secure web-enabled reports
• Supports multilingual voice
recordings in an unlimited
number of languages
Service and Quality beyond Compliance
16
Facilities
Bilcare Global Clinical Supplies,
a true global service provider,
has manufacturing, packaging,
labeling, storage and distribution
facilities in the US, UK and
India. We have the sophisticated
systems required to manage
the production and logistics of
clinical trial supplies on a global
basis. Bilcare provides best-in-
class services for clinical supplies
management, research and
distribution in more than
50 countries.
Service and Quality beyond Compliance
Americas
Bilcare GCS Americas
300 Kimberton Road
Phoenixville, PA 19460
Phone: 610-935-4300
Toll Free: 800-310-4445
Fax: 610-935-4321
Email: gcsquery@bilcare.com
Highlights
• 153,000 sq. ft. facility spread
over 14 acres
• FDA licensed
• 10 Primary and 16 Secondary
Packaging rooms
• DEA licensed for controlled
substances (Schedule I-V)
17
Facilities
Europe Highlights
Bilcare GCS Europe • 35,000 sq. ft. MHRA
Waller House licensed facility
Elvicta Business Park • 14 packaging rooms for
Crickhowell primary and secondary
Powys NP8 1DF packaging
UK • Secure drug storage ambient /
Phone: +44 (0) 1873-812182 refrigerated / -20°C / -70°C
Fax: +44 (0) 1873-810836 • 1,600 pallet locations
Email: gcsquery@bilcare.com • Control substances
secure vaults
• Continuous monitoring
of  temperature and humidity
Service and Quality beyond Compliance
18
Facilities
Asia-Pacific Highlights
Bilcare GCS Asia-Pacific • A dedicated 25000 Sq. ft. facility
1028 Shiroli, • State FDA licensed facility for
Rajgurunagar, carrying out packaging, storage
Pune - 410 505, & distribution operations of
India. clinical trial supplies
Phone: +91 02135 304200 • Licensed for Handling
Fax: +91 02135 224068 Narcotics & Psychotropic Drug
Email: gcsquery@bilcare.com Substances (NDPS/ Controlled
Drug Substances )
• World class SOPs in line
with USFDA and MHRA
requirements
• 3 Primary and 10 Secondary
Packaging High Class
maintained GMP suits with
validated and qualified
equipments
• ISO Class 7 (Class 10000)
areas for primary packaging
operations
• ISO Class 8 (Class 100000)
areas for secondary packaging
operations
Service and Quality beyond Compliance
• Dedicated & secure
warehousing, storage &
distribution areas with restricted
access at 15-25 Deg C,2-8 Deg
C,-20 Deg C & -70 Deg C
• Highly secure vaults for
controlled drug substances
• Customized Inventory
Management through 21 CFR
Part 11 compliant SAP ECC 6.0
system & 24 x7 Inventory &
Temperature –Humidity data
visibility through Customer
Web Portal
• 24 x 7 Monitoring &
Controlling of temperature &
humidity inside facility through
21 CFR Part 11 compliant
Building Management System
elephantdesign.com
• Global Supply Chain & Logistics
Network
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