bilcare gcs capabilities presentation 2009 printable

8/7/2019 Bilcare GCS Capabilities Presentation 2009 Printable

1/54

Service and Quality Beyond Compliance


2/54

An international organization providing the

worldwide pharmaceutical industry withexcellence in formulation development, clinicalmanufacturing, analytical support, packaging and

global distribution of clinical trial supplies.

Our Vision: Transforming Health Outcomes Touching Lives

Our Values: Speed. Innovation. Happiness.

Bilcare GCS Overview


3/54

INNOVATION

TRUST

COMMITMENT AND FACE

Delivery BeyondCompliance

Project Mgmt

Contract Mgmt

Integrated

Quality

Assurance

System

Integration

Technology

Optima

Blister Pack

Design

Global Labeling

System

IVRS Next-Gen

Compliance

Why Bilcare GCS?

Flexibility

IN-Sourcing

Geographic

Locations

Quantity /

Capacity

Speed of

Turnaround

Knowledge

One Stop Shop

for Clinical

Supplies

Deep Customer

Knowledge and

Relationship

Focus

Experience

Unique

India Research

Academy

Dedicated India

Campus


4/54

Bilcare History

2008

1982 Bilcare Founded, Pune India

2002 Singapore Facility Begins Operations

2005 Bilcare GCS Americas Clinical Supplies Facility Acquired

2006 Bilcare GCS Europe Clinical Supplies Facility Acquired

2007 Bilcare Research Academy Establishes Alliance with

the Association of Clinical Research Professionals (ACRP)

2005 Bilcare GCS Asia (India) Clinical Supplies Facility Complete

Bilcare GCS Americas Completes Packaging Suites; ExpandsPhase III Manufacturing Capabilities

Bilcare GCS Asia (India) Completes Logistics and LabelOperations Expansions


5/54

Bilcare GCS Global Facilities


6/54

Bilcare GCS Americas

Locations

300 Kimberton Rd. Phoenixville, PA 19460

1041 W. Bridge St. Phoenixville, PA 19460

DEA Licensed for Controlled Substances

FDA Registered Facility

Facilities

26 Production Suites Total

Kimberton Rd.Administrative Offices

10 Primary and 12 Secondary Production Suites

Warehouse

W. Bridge St.Administrative Offices

4 Secondary Production Suites

Warehouse

Global Facilities Americas


7/54

Bilcare GCS Europe

Location

Waller House

Elvicta Business Park

Crickhowell, Powys NP8 1DF

Wales, UK

MHRA Licensed Facility

Facilities

14 Production Suites Total

Couzens BuildingAdministrative Offices

Production Suite 4 Suites (Primary/Secondary)

Waller HouseAdministrative Offices

Production Suite 10 Suites (Primary/Secondary)

Warehouse

Global Facilities Europe


8/54

Expansion: Bilcare GCS Europe

Expansion 2009Storage and Distribution

Secure Drug Storage & Returns,Ambient / CRT / Refrigerated / Frozen

Yielding 1,000 Additional Pallet Locations Control Substances Secure Vaults

Secure Warehousing Bulk and CriticalComponents

Global Facilities Europe


9/54

Bilcare GCS Asia India

Location

307,1028 Shiroli,

Rajgurunagar, Pune 411030

India 125 Acre Campus

Licensed for Controlled Substances

Facilities

11 Production Suites Total Administrative Offices

4 Primary and 7 SecondaryProduction Suites

Warehouse

Global Facilities AsiaIndia Facility


10/54

Expanded Capabilities

Bilcare GCS Asia India

Operations

New Label Control Facilities

Storage and Distribution

Control Substances Secure Vaults

Secure Warehousing Bulk and CriticalComponents

Secure Drug Storage, Ambient / CRT /Refrigerated / Frozen

Greater Asia Logistics Operations

Global Facilities AsiaIndia Facility


11/54

Bilcare GCS Asia Singapore

Location

52, Changi South Street 1

Singapore 486161

GMP Certified Facility

Highest Standard Facility in Asia

Facilities

Administrative Offices 2 Secondary Production Suites

Warehouse

Global Facilities AsiaSingapore Facility


12/54

Bilcare GCS Global Capabilities

Clinical

Research &

Development

Clinical

Manufacturing

Packaging &

Labeling

Global

Logistics &

Supply

Chain

Management

IVRS

IWRS

Global

Comparator

Sourcing

IN-Sourcing

Offsite

Clinical

Supplies

Operations

Project Management

Quality Foundation & Services

You


13/54

Global Capabilities Project Management

Bilcare

EuropeProject

Management

Bilcare

N. AmericaProject

Management

BilcareAsia

ProjectManagement

BilcareStrategic

Management

You


14/54


Bilcare GCSProject

Management

ProactiveCommunication

GlobalExperience

Continuous

Training

Functional

Expertise

LessonsLearned


15/54

Communication Customized Communication Plan

Kick-Off Meetings

Team Meetings

Measuring Success Overall Performance

On-time Production

On-time Shipments and Logistics Processing of Import/Export Materials and

Supplies

Evaluation of Bilcare Locations in General andSpecific Functions

Gantt Charts


Dedicated Project Management Globally and Site Specific (Bilcare Locations)

Label Control Teams

Logistics Teams

Lessons Learned Review of Goals Reached & Attempted

Review of Metrics in Reaching Goals -Performance

Evaluation of Communication

Gantt Charts

Bilcare GCS Project ManagementThe Key to Your Projects Success


16/54

Global Capabilities Clinical R&D

FormulationDevelopment

AnalyticalServices

ClinicalResearch &

Development


17/54

Bilcare GCS Analytical ServicesGMP qualified scientists oversee comprehensivetesting of your materials. We take extra steps toensure that your products comply with regulatorystandards.

Seven Analytical Laboratories

Spectroscopy Laboratory

Dissolution Laboratory

Chromatography Laboratory

Physical Testing Laboratory Sample Preparation Laboratory

Development Laboratories

Stability Storage Suite

Global Capabilities Analytical


18/54

Bilcare GCS Analytical ServicesOur dedicated personnel provide technical supportduring each phase of your products development

and manufacturing.

Analytical Laboratory Testing

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



19/54

Bilcare GCS Analytical ServicesOur dedicated personnel provide technical supportduring each phase of your products development

and manufacturing.

Analytical Laboratory Testing (Continued)

Accelerated Drug Stressing

Dissolution Profile Testing Extractable Studies for Parenteral Products

Competitor Analysis for Unbiased De-Formulation

Hygroscopicity Studies

Method Development and Validation for All Phasesand All Components in Development of the following:

Drug Substance

Non-Compendial Excipients

Drug Product

Process Development Support



20/54


21/54

Bilcare GCS Analytical ServicesBilcare GCS Americas can be utilized to supportAnalytical Research and Development for both EU

and Asia facilities.


GLOBAL CAPABILITIES AMERICAS EUROPE ASIA

Analytical & Research Services

Analytical Laboratory 1 Release Testing 2 Stability 2 2 Method Development 1 1 Cleaning Verification Controlled Substance Management 1 1


Analytical & Research Services

Analytical Laboratory 1 Release Testing 2 Stability 2 2 Method Development 1 1 Cleaning Verification Controlled Substance Management 1 1

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas 2 - Achieved with Support from Bilcare GCS Americas or Local Third Party


22/54

Bilcare GCS Formulation DevelopmentThe Bilcare team of formulation specialists is alwaysready to provide you with expeditious innovativeformulations for your clinical trials.

Pre-Formulation Services

Chemical Compatibility & Reactivity to Packaging Substrates

Physical Properties & Product Characterization

Accelerated Degradation

API-Excipient Interaction Studies

pKa Determination

Hygroscopicity Studies

Photostability of API

Prototype Evaluations

Reverse Engineering

Global Capabilities Formulation


23/54

Bilcare GCS Formulation DevelopmentFollowing the determination of the appropriatecomposition, the Bilcare formulation staff focus theirinterest on the development of the process for makingyour clinical trial material.

Formulation Development

Phase I-IV Formulation Development and Reformulations

Determine Blending Times for Tableting & Encapsulation and

Analysis of Characteristics (Blending Time, Bulk Density,

Content Uniformity, and Flow Characteristics)

Overencapsulation and Comparator Product Blinding

Develop Matching Placebo Product / Comparator Supplies

Develop Both Ethical and Over-The-Counter Products: tablets

(immediate and controlled release), powders, liquids,

suspensions, emulsions, creams and ointments, lotions Develop Line Extensions in the Above Dosage Forms



24/54

Bilcare GCS Formulation DevelopmentBilcare has the technical expertise, experience, andrange of technical support services to help you

achieve your clinical trial goals, troubleshoot existingproducts or improve current products.

Technical Services

Experienced Professionals to Troubleshoot Commercial

Products

Formulation Optimization & Evaluation of New Raw Materials

in Existing Products

Technical Transfer of Products from R&D to Production

Facilities

Process Optimization & Scale-up and Assessment of Current

Products & Recommendations for Improvements to Modernize

Existing Manufacturing / Clinical Supplies Processes



25/54

Bilcare GCS Formulation DevelopmentBilcare GCS Americas can be utilized to supportFormulation Development for both EU and Asia

facilities.



Formulation Development 1 1 Controlled Substance Management


Formulation Development 1 1 Controlled Substance Management

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas


26/54

Bilcare GCS Clinical ManufacturingOnce a drug has been formulated, Bilcare hasmanufacturing facilities that can provide fast, efficient

and agile manufacturing of solid dosage forms as wellas liquids, creams, and ointments.

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

Global Capabilities ClinicalManufacturing, Packaging & Labeling


27/54

Bilcare GCS Clinical ManufacturingOur unique approach enables us to support customerrequirements for short-term studies as well as large-

volume ongoing projects.

Dosage Forms Manufactured

Controlled and Immediate-Release Tablets

Capsules (Multi-Fill, Powder, Solid, Liquid, Semi-Solid,

Solid/Liquid Combination Fills)

Powders and Dry Powders

Liquids Suspensions

Emulsions

Creams & Ointments

Lotions



28/54

Bilcare GCS Clinical PackagingWe help you select the right packaging solutions,complete production and deliver a final product that

meets your high standards through comprehensivepackaging research that produces the best, customizedand innovative clinical packaging materials.

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 Temp. (Refrigerated / Frozen) Packaging


Tube Filling

Creams

Ointments


29/54

Bilcare GCS Clinical LabelingBilcare provides support with full labeling services andinnovations for your product, meeting all of your high

standards and expectations. We pay strict attention toglobal regulatory requirements.

In-House Label Generation, Production

Label Types Produced

Single & Multi-Panel

Single & Multi-Lingual

Randomized & Open

Sequentially Numbered

Variable Text

32 Languages Fully Supported

Code Break & Randomization Generation

Client-Supplied Randomization Fully Supported 21 CFR Part 11 Compliant PRISYM Software for Label Design



30/54


The Bilcare GCS Integrated ProcessOur clinical manufacturing, packaging & labelingcapabilities fall under one powerful comprehensive pathin meeting all of your clinical project needs.

The Benefits

A Single Point of Contact

A Single Audit for You to Complete and Sustain

Single Format and Management of Batch Records and

Documentation

Minimized Manufacturing Timeline, Risk and Documentation

Delays that can Occur When Transferring Materials BetweenMultiple Vendor Strategies

Our Quality Process Ensures that We Have Produced:

The Right Product

In the Right Container

With the Correct Label


31/54

Bilcare GCS Clinical Manufacturing,Packaging & Labeling

Our global clinical services expertise supports

customers in every decision-making process.



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


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

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas and/or Europe 2 - Achieved with Support from Bilcare GCS Americas


32/54

Bilcare GCS Global Logistics &Supply Chain ManagementBilcare can store and ship your materials to sitesworldwide under any array of conditions. You canrely on our proven global network to have the rightproduct to the right site under the right timeline.

Our Advantage

Customized Logistics Solutions Import / Export of Clinical Trial Material

Depot Management

Conditions Supported: Ambient, Refrigerated

(2-8C) & Frozen (-20C, -70C, -80C)

Cold Chain Solutions

Global Distribution Management

Specialized Logistics Project Management Controlled Substance Management

Global Capabilities Logistics &Supply Chain Management


33/54

Bilcare GCS Global Logistics &Supply Chain ManagementIn addition to our vast global storage & distributioncapabilities, we provide reconciliation anddestruction services for returned goods withoptimal accuracy and efficiency.

Returns & Destruction Customer and Project Specific Returns and

Reconciliation Protocols

Ample and Secured Storage

Regulatory Compliance and Documentation

Support

Updated and Complete Documentation on

Destruction



34/54

Global Supply Chain Depot Network



35/54

Bilcare GCS Global Logistics &Supply Chain ManagementThere are many smart reasons for using BilcareGlobal Logistics services to achieve success inyour clinical trials needs.



Global Logistics & Distribution Cold Chain Shipping Ambient (15-25

C)

Refrigerated (2-8C)

Frozen (-20C)

Deep Freeze (-70

C/-80

C)

Inventory Management Returns & Destruction Controlled Substance Management


Global Logistics & Distribution Cold Chain Shipping Ambient (15-25

C)

Refrigerated (2-8C)

Frozen (-20C)

Deep Freeze (-70

C/-80

C)

Inventory Management Returns & Destruction Controlled Substance Management

- Fully Supported


36/54

Bilcare GCS IVR / IWR ServicesThere are a number of compelling benefits for using theBilcare GCS IVRS/IWRS for a more streamlined andsuccessful clinical trial.

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 GuidanceSystem Flexibility

Use Statistical Scheme

Balance at Any Level

Can Accommodate Stratifications

Global Capabilities IVR / IWR Services


37/54

Bilcare GCS IVR / IWR ServicesPart of the Bilcare GCS Clinical Supply Chain is anInteractive Voice/Web Response System.

Access via Phone or Web

User Friendly and Easy to Use

Data Entry Direct from Source Toll-Free Phone Lines

Secure Entry

Available 24/7

Multilingual



38/54

Bilcare GCS IVR / IWR ServicesThere are a number of compelling benefits for using theBilcare GCS IVRS/IWRS for a more streamlined andsuccessful clinical trial.

Automated System

Automates Patient Enrollment and Randomization

Captures Data

E-Diaries

Tracks Clinical Supplies Inventory and

Automatically Re-Supplies Clinical Trial Materials Ensures No Interruptions to Enrollment Due to

Clinical Supplies Problems

Streamlined Setup and Validation of New Studies

Accelerated Process for Moving from Protocol to

User Acceptance Testing (UAT)



39/54

Bilcare GCS IVR / IWR ServicesBilcare GCS system is fully customizable and flexible toensure that all of your clinical trial needs are metwithout any interruption.

Study Material Management

At Warehouse

At Depots

At Sites

Individual Patient Assignments

Shipments

Phone or Web Management Site Initiation

Patient Enrollment

Randomization Drug Management



40/54

Why Bilcare GCS IVR / IWR Services?

World-class speed for setup and validation ofnew studies less than four weeks from UserRequirement Specification (URS) approvals toUser Acceptance Testing (UAT)

Minimizes Per-Patient Cost of Trial Rapid Scale Out for New Sites, Dial-In Locations

(Point of Presence)

Easy to Validate, Easy to Purchase, and Easy to

Modify Ease of Access to Study Metrics

Extremely Flexible

Prevents Drug Wastage

Prevents Patient Over-Enrollment



41/54

Bilcare GCS IVR / IWR ServicesBilcare GCS IVR / IWR services can be utilized tomanage any global study from any location.



IVRS / IWRS

Design 1

1

Management 1 1


IVRS / IWRS

Design

1

1

Management 1 1

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas


42/54

Bilcare GCS Comparator SourcingProcurement of comparator drugs is often anextremely challenging aspect of implementingclinical studies. Because of Bilcare GCS globalpresence and experience, this aspect is achievedefficiently and effectively on a consistent basis.

Our Global Sourcing Network Supply Network

Drug Manufacturers Direct

Wholesalers

Established Relationships withManufacturers and Global Wholesalers

Market Agility: The Ability to Purchase Any

Product from Any Global Market

Your Confidentiality in Mind

Global Capabilities Comparator Sourcing


43/54

Bilcare GCS Comparator SourcingSince Bilcare GCS has facilities in North America,Europe, and Asia, procurement of comparatordrugs can be very efficiently implemented on yourcompanys behalf for studies around the world.

Global Capabilities Comparator Sourcing


Comparator Sourcing

Comparator Sourcing Comparator Distribution Mgmt


Comparator Sourcing Comparator Sourcing Comparator Distribution Mgmt

- Fully Supported


44/54

Bilcare GCS Global IN-SourcingBilcare GCS major strength lies in its ability tofully integrate innovative solutions and services

throughout a drugs clinical trial life cycle Onsiteor Offsite. We bring all of our global expertise andexperience to you.

Clinical Supplies Operations at Your Site Staffing and Staff Augmentation

Operations / Production All Verticals

Complete Project Management

Quality / Regulatory Services

Full Accountability / Maximum Flexibility

The Bilcare GCS Promise Upheld: Service

and Quality Beyond Compliance Regardless of the Location of the Project

Global Capabilities IN-SourcingOffsite Clinical Supplies Operations


45/54

Bilcare GCS Global IN-SourcingBilcare GCS vision and values are carried with uswherever we operate. If your clinical trial needs

can not come to us, we can come to you to achievethe success that you are striving for in all of yourclinical supplies needs.

Global Capabilities IN-SourcingOffsite Clinical Supplies Operations


IN-Sourcing Offsite Clinical Supplies Ops.

Formulation Development Analytical & Research Services Clinical Manufacturing

Packaging

Labeling IVRS/IWRS Global Logistics & Distribution Quality Assurance Services


IN-Sourcing Offsite Clinical Supplies Ops.

Formulation Development Analytical & Research Services Clinical Manufacturing Packaging Labeling IVRS/IWRS Global Logistics & Distribution Quality Assurance Services

- Fully Supported


46/54

Bilcare GCS Quality FoundationBilcare GCS is registered with the DEA as aManufacturer, Distributor, Exporter, Importer and

Analytical Laboratory of Controlled Substances.

Regulatory HistoryBilcare GCS Americas

Establishment License (FDA) No 483s License 2531012

Last Inspection: January 2007

DEA Licensing No Citations / Issues

DEA Manufacturers License (I-V) RB0326923

DEA Distributor License (I-V) RB0326771

DEA Exporter License (I-V) RB0326810

DEA Importer License (IIIN, IV) RB0326822

DEA Analytical License (I-V) RB0326795 Last DEA Inspection: September 2006

Global Capabilities Quality Foundation & Services


47/54

Bilcare GCS Quality FoundationWe strive everyday to seek perfection in terms ofquality in the eyes of you (our client) and regulatory

agencies.

Regulatory History

Bilcare GCS Europe

MHRA Licensed Site Number 12225MHRA Audit March 3, 2008 No Critical or Major Observations

Manufacturers Authorization (Investigational Medicinal Products)

MA (IMP) 10284

6 named QPs

Manufacturers License (Assembly Only) AO/10284/1

Manufacturers Specials License MS/10284/1

Wholesale Dealers License WL/10284/1

Wholesale Dealers (Import) License WI/10284/1

Home Office Controlled Drugs Licenses



48/54

Bilcare GCS Quality FoundationOur Standard Operating Procedures (SOPs) can bemade available for your review during your audit of our

facilities. Feel free to schedule an audit or visit toBilcare soon.

Regulatory History

Bilcare GCS Asia

Controlled Substance License (Storage and Distribution)

Manufacturing License from State FDA

Storage & Distribution License from State FDA

NDPS I License from State FDA

Planned MHRA Inspection to Take Place Soon



49/54

Bilcare GCS Quality ServicesBilcare GCS offers QP Services in accordance withthe EU requirement that all investigational,

medicinal products manufactured or imported byorganizations holding a MA IMP have available aQualified Person to approve and release eachbatch of IMP for clinical trial use.

QP Services

Audit of Manufacturing Sites Within and

Outside the EU

Assessment of Each Batch for Certification

Prior to Release. May Include, as

appropriate:

Batch records, including control reports

In-process test reports and release reports

demonstrating compliance with the product

specification file, the order, protocol andrandomization code.



50/54

Bilcare GCS Quality ServicesQPs are assigned projects according to theirspecialized expertise and have personal and legal

responsibility as described in the EU Clinical TrialDirective (2001/20/EC) to ensure the investigationalproducts are produced in accordance with EUGMP and the clinical trial authority.

QP Services (Continued)

Production Conditions

The Validation Status of Facilities,

Processes & Methods

Examination of Finished Packs

Audit the Results of Any Analyses or Tests

Performed after Importation

Stability Reports

The Source and Verification of Conditions ofStorage and Shipment



51/54

Bilcare GCS Quality ServicesBilcare has a team of six Qualified Persons (QPs)with wide experience in the manufacture and

supply of Investigational Medicinal Products.QP Services (Continued)

Audit Reports Concerning the Quality System of

the Manufacturer

Documents Certifying that the Manufacturer isAuthorized to Manufacture Investigational

Medicinal Products or Comparators for Export by

the Appropriate Authorities in the Country of

Export

Regulatory Requirements for Marketing

Authorization, GMP Standards Applicable and Any

Official Verification of GMP Compliance

All Other Factors of Which the QP is Aware that

are Relevant to the Quality of the Batch Physical Examination of Packaging



52/54

Bilcare GCS Quality ServicesBilcare GCS Europe can be utilized to support QPServices for both Americas and Asia facilities.



QP Services 1 1GLOBAL CAPABILITIES AMERICAS EUROPE ASIA

QP Services 1 1 - Fully Supported 1 - Achieved with Support from Bilcare GCS Europe


53/54

Assuring Success: The Next Steps

Your Strategic Alliance With Us

Bilcare GCS will facilitate your speed to market through utilization of vendor

capacity, flexibility and expertise; ultimately reducing fixed cost therebystrengthening your worldwide competitiveness.

The Next Steps Alliance Objective

Alliance Leadership

Integration Process

Realistic Potential

Commitment on Technology

Effective Governance Structure Communications Plan

Timeframe for Action

Internal and External Cross FunctionalCollaborations


54/54

We Look Forward to Meeting Your Needs!