bilcare gcs brochure

8/8/2019 Bilcare GCS Brochure

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Global Clinical Supplies

www.bilcaregcs.com


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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

ContentWith 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.

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.

The clinical trial

landscape is changing

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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

Partnering with customersto improve patient

healthcare outcomesexperience, resources, and

capabilities that cover the full

spectrum of services across

the supply chain, from pre-

formulation to global logistics and

distribution, Bilcare GCS

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.

Innovation

Global capabilities with local service.Best-in-class project managementSeamless support

Quick turnaround

Flexibility

Project managementContract managementIntegrated quality assurance

System integration

Delivery beyondcompliance

Knowledge

Technology

One-stop-shop for clinical suppliesIndustry-leading experience and resourcesIntegrated drug development services

State-of-the-art facilities and technologies

Value through

innovationBilcare GCSs breadth of

knowledge is unique, but our real

point of difference is the ability

to innovate and collaborate with

customers and partners to solve

complex clinical trial challenges.


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With best-in-class manufacturing

plants and facilities on three

continents, Bilcare GCS delivers

end-to-end solutions that support

a drug through the entire clinical

trial life cycle.

Our services for solid, semi-solid,

liquid, DEA (CI-V), scheduled

drug and biotech clinical trial

materials (CTM) satisfy a broad

End-to-end services foryour global clinical

supply needs

Quality Foundation

SERVICES

Formulation Development

Analytical & Research Services

Clinical Manufacturing,

Packaging, & Labeling

Interactive Voice/WebResponse System

Global Logistics &Supply ChainManagement

Depot Management

QP Services

Comparator Sourcing

In-Sourcing CTM Services

BILCARE GCS GLOBAL CAPABILITIES AMERICAS EUROPE ASIA-PACIfIC

AnALyTICAL & RESEARCh SERvICES

Analytical Laboratory 1

Release Testing 2

Stability 2 2

Method Development 1 1

Cleaning Verification

Controlled Substance Management 1 1

fORMULATIOn DEvELOPMEnT

Controlled Substance Management 1 1

CLInICAL MAnUfACTURInG

Solid, Liquid, Creams 1

Encapsulation 1

Over-encapsulation 1

Controlled Substance Management 1

PACkAGInG

Bottling

High Speed Bottling 2 2

Blistering

High Speed Blistering 1

Pouching 1

Tube Filling 1

Blister Carding

Label Application and Kit Assembly

Controlled Substance Management

Comparator Sourcing & Acquisition

LABELInG

Label design

Label production

Label procurement

GLOBAL LOGISTICS & DISTRIBUTIOn

Cold Chain Shipping

Ambient (15-25C)

Refrigerated (2-8C)

Frozen (-20C)

Deep Freeze (-70C/-80C)

Inventory Management

Returns & Destruction

Controlled Substance Management

IvRS / IWRS

Design 1 1

Management 1 1

COMPARATOR SOURCInG

Comparator Sourcing

Comparator Distribution Mgmt

In-SOURCInG OffSITE CLInICAL SUPPLIES OPS.

Formulation Development

Analytical & Research Services

Clinical Manufacturing Packaging

Labeling

IVRS/IWRS

Global Logistics & Distribution

Quality Assurance Services

QUALITy SERvICES

QP Services 1 1

Regulatory Support

Archiving Services

- 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

range of requirements from

pre-formulation research and

development, manufacturing,

analytical services and clinical

supplies packaging and labeling

to IVRS, QP services, controlled-

temperature (cold chain) CTM

storage, worldwide distribution

and returns and destructions

accountability.


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Reliable formulations for

optimal clinical outcomesWith 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-formulationBilcare 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

Formulation DevelopmentBilcare 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 ServicesBilcare 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 Analytical & Research Services

Quality analytical services

within your timelinesBilcare GCS analytical and

research services evaluate the

performance of formulations

using various investigative

testing procedures, enabling

the foundation for

future developments.

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

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 25C/60%

RH, 30C/65% RH, 40C/75%

RH, 25C/40% RH, 40C/25%

RH, 5C, and photo stability

Service and Quality beyond Compliance Service and Quality beyond Compliance


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Best-in-class

manufacturing

Clinical Manufacturing

Bilcare GCS offers comprehensive

clinical manufacturing, packaging

and labeling solutions to

maximize client investments,

minimize development time and

reduce overall costs.

Clinical ManufacturingBilcare 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

Innovative

packagingClinical PackagingThrough 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.

Primary and Secondary Packaging

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

Tube filling

- Creams

- Ointments

Packaging Research and

Audit Services

Evaluation of packaging efficacy

through physicochemical

requirements and actual field

performance

Packaging cost evaluation

including indirect costs such as

transportation and storage

Evaluation of packaging

productivity based on process

and machine efficiency,

machine time utilization and

production waste

Compliance with cGMP

standards as well as USA and

international regulations

and guidelines

Quality control and quality

assurance evaluations

Packaging and LabelingService and Quality beyond Compliance Service and Quality beyond Compliance


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Innovative

packagingClinical LabelingBilcare 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

Packaging and Labeling

Our unique approach to project

management includes the

generation of a concise and agreed

upon Integrated Project Plan

complete with full visibility.

This effectively communicates the

project scope, resources and cost

with the added ability of being

able to identify issues and assess

risks that may threaten the critical

path of a project.

End-to-end Project

ManagementCommunication Customized

Communication Plan

Kic k-off meetings

Team meetings

Measuring Success Overall performance, quality

and accuracy

On-t ime production

O n-time shipments

and logistics

Processing of import/export

materials and supplies

Evaluation of Bilcare locations in

general and specific functions

Gantt charts

Project Management ServicesService and Quality beyond Compliance Service and Quality beyond Compliance

Dedicated ProjectManagement Globally and site specific

(Bilcare locations)

Label control teams

Logistics teams

Regulatory Support and

Archiving Services

Lessons Learned Review of goals reached &

attempted

Review of metrics in reaching

goals -performance

Evaluation of communication


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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.

Reliable supply chain

management and logisticsEnd-to-End Supply Chain

Solutions Customized logistics solutions

Import / export of clinical trial

material

Depot management

Conditions supported:

ambient, refrigerated (2-8C) &

frozen (-20C, -70C, -80C)

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

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)

The Bilcare

IVRS/IWRS edgeServices Customized IVR/IWR system

programming

Patient enrolment and

randomization

Pati ent diaries

Site administration and tracking

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


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 SubstanceManagementBilcare GCS is registered with

the DEA and the Government

of UK as a manufacturer,

distributor, exporter, importer and

analytical laboratory of controlled

substances.

Real-time reporting and

tracking via web

Technical support and training

for staff and investigators

Outbound fax and emails

Adaptive trials

Predictive inventory


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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.

FacilitiesAmericas

Bilcare GCS Americas

300 Kimberton Road

Phoenixville, PA 19460

Phone: 610-935-4300

Toll Free: 800-310-4445

Fax: 610-935-4321

Email: [email protected]

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)

FacilitiesEurope

Bilcare GCS Europe

Waller House

Elvicta Business Park

Crickhowell

Powys NP8 1DF

UK

Phone: +44 (0) 1873-812182

Fax: +44 (0) 1873-810836


Highlights

35,000 sq. ft. MHRA

licensed facility

14 packaging rooms for

primary and secondary

packaging

Secure drug storage ambient /

refrigerated / -20C / -70C

1,600 pallet locations

Control substances

secure vaults

Continuous monitoring

of temperature and humidity



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FacilitiesAsia-Pacific

Bilcare GCS Asia-Pacific

1028 Shiroli,

Rajgurunagar,

Pune - 410 505,

India.

Phone: +91 02135 304200

Fax: +91 02135 224068


Highlights

A dedicated 25000 Sq. ft. facility

State FDA licensed facility for

carrying out packaging, storage

& distribution operations of

clinical trial supplies

Licensed for Handling

Narcotics & Psychotropic Drug

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

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

Global Supply Chain & Logistics

Network

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for distribution without prior written approval from Bilcare Ltd.

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