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BIO PHARMA & HEALTHCARE DIVISION CAPABILITIES & IQP PARTNERSHIP
CAVALIER PHARMA LOGISTICS VISION
● Cavalier Pharma-Logistics is a trusted
and critical service provider to
pharmaceutical companies engaged in
the movement of pharmaceutical
products.
● We excel in the global shipping of time
and temperature-sensitive drugs,
clinical trial supplies, vaccines and
dangerous goods.
● Through our specialized services and
attention to detail we provide unique
customer specific solutions enabling
our customers to have peace of mind
and visibility to there supply chain and
product while in our care.
CAVALIER PHARMA LOGISTICS VISION
● To be a Global Service Provider of
choice.
● Provide logistics competency to the
pharmaceutical industry.
● Help our customers create and
sustain a valuable advantage within
their industry.
● To seek the ultimate goal of providing
added value and mentoring long term
business partnerships.
WHAT IS DRIVING TODAY’S SUPPLY CHAIN,
THE GLOBAL INDUSTRY TRENDS AND WHAT ARE
THE GEOGRAPHICAL CHALLENGES?
Cavalier offers a clear and precise
strategy when handling your
global clinical logistics.
● Our goal is to improve your supply
chain efficiencies.
● Cavalier seeks and develops practices
that minimize cost and risk.
● We understand Global Regulation
and know how to deal with issues
and processes around the world.
● Cavalier knows the critical
requirements of being a good clinical
supply chain partner.
A SUSTAINABLE COMPETITIVE ADVANTAGE
INTRODUCTION TO IQP
The ORCA system has been introduced as a reusable
logistics asset within the IQP certification scheme
● Offers GDP compliance
● World class temperature controlled distribution
performance and operational simplicity.
● The Intelsius Qualified Partner (IQP) certification
program provides a quality management framework
that will enable you reuse the ORCA with assurance
and maximize the performance of your logistics
asset.
● The Qualified Intelsius Partner Program is designed
to enable maximum performance from your ORCA
systems every time.
● Giving our customers, confidence that their payload
will arrive intact every time.
● A turn key cold chain solution delivers on time and at
temperature !
COMPARISON
PROPOSITION TO THE MARKET
• Traditionally packaging and logistics have
been considered as separate purchases.
• This has led Pharmaceutical companies
controlling the packaging assets and then
outsourcing the movement of the product.
• In order to get the benefit of the higher
performance and cost savings, the ORCA
must be reused – this means someone has
to take charge of tracking and managing
the asset.
• Pharmaceutical companies do not wish to
do this, but it suits the core competencies
of logistics companies.
THE BENEFIT OF THE IQP
Partnering in the IQP ,we can assuage any
quality fears within pharmaceutical companies
that are natural when outsourcing activities.
• The IQP now offers a new solution to old
problems.
• The program offers benefit from economies
of scale
• By performing the process for multiple
companies we gain benefits they cannot
achieve individually.
CAVALIER PACKAGING SOLUTIONS
ORCA°
CAVALIER PACKAGING SOLUTIONS:
TECHNOLOGY
• Vacuum Insulation Technology (VIP)
A vacuum insulated panel (VIP) is a form of thermal
insulation consisting of a nearly gas-tight enclosure
surrounding a rigid core, from which the air has been
evacuated.
• Advanced Plant-based Phase Change Material (PCM)
A phase-change material (PCM) is a substance with high
heat fusion which, melts and solidifies at a certain
temperature, capable of storing and releasing large
amounts of energy. Heat is absorbed or released when
the material changes from solid to liquid and vice versa.
• Thermochromic Labels
Thermochromic is the property of substances to change
colour due to a change in temperatures.
CAVALIER PACKAGING SOLUTIONS:
ADVANTAGES
● Outperforms the competition every time
● 2-8° C / CRT / -80° C available
● ISTA Certified Laboratory
● Qualified against all recognized thermal challenges
● Smart inventory
● Universal pack-out
● Thermo chromic Labels to show ready to use
● Packing instructions printed inside every lid
● 3D Barcode to get packing instructions through
smart phone
● Reusable solution
● IATA Time & Temperature Label pre-printed
CAVALIER PACKAGING SOLUTIONS:
ADVANTAGES
● Outperforms the competition every time
● 2-8° C / CRT / -80° C available
● ISTA Certified Laboratory
● Qualified against all recognized thermal challenges
● Smart inventory
● Universal pack-out
● Thermo chromic Labels to show ready to use
● Packing instructions printed inside every lid
● 3D Barcode to get packing instructions through
smart phone
● Reusable solution
● IATA Time & Temperature Label pre-printed
BIO PHARMA HEALTHCARE SERVICE CENTER
The cGMP storage and distribution facilities located in Maryland and Los
Angeles are temperature controlled with Validated Controlled Ambient
Temperature Storage (15°c – 30°c) of Scheduled Pharmaceuticals, Reagents,
Life Science.
• Validated -20 °c and -80 °c uprights.
• Validated 2 °c to 8 °c & ambient storage
• 43,000 square feet secure pharma grade
facility.
• A 100kVA natural gas generator provides
redundant power.
• Three kit assembly rooms for specific
packaging.
• Operating the facilities under cGMP
guidelines, 21 CFR Parts 210-880
• Supported by audit ready SOPs for all
processes.
• The Maryland facility is licensed by the
DEA for storage of Schedule 3-5
Pharmaceuticals.
• Over 1,000 icage pallet positions.
THE
● The Pharma Logistics Network has been
established by industry professionals to meet the
growing and recognized need for a truly
professional Global Association of specialist
forwarders where capability, resources, and
infrastructure are in place to meet the most
demanding client needs in the Pharmaceutical
Industry with particular emphases on Bio Pharma
Cold Chain requirements.
● There will be just one accredited and approved
member in each major strategic location and
beyond to ensure that the Pharmaceutical
Industry has a truly independent, focused, and
specialized core of Forwarding Companies that
don’t just say “yes we can do this” but have the
experience, dedication, and credentials to do the
job and have met an exacting membership
criteria.
GLOBAL PLATFORM
A consistent approach to cold chain distribution based upon a global platform
CAVALIER PHARMA NETWORK:
COLDCHAINLOGISTICS
• Temperature
Controlled
Solutions
• Multi use
package lease
• Clinical Trial
Logistics
• Pharma IT
Platforms
GLOBALCOMPETENCY
• Cold Chain
Services
• Dedicated
support
teams
• GxP Protocol
and Process
• Global
Visibility
WAREHOUSE
• Regional Cold
Chain facilities
• Pharma
Logistics
trained
experts
• Pharma Grade
Cold Storage
GMP
• Risk
Management
competencies
• Global
Footprint
GLOBALFORWARDINGSPECIALIST
• Pharma
specific SOP
library
• Dedicated
Process
• Dedicated
People
• Data Device
Option
• Validated
packing
solutions
A consistent approach to cold chain distribution based upon a global platform
GOOD DISTRIBUTION PRACTICE (GDP)
● Applies to all drugs including active pharmaceutical ingredients, excipients,
intermediates and finished goods.
● The pharmaceutical industry operates at a high level of quality assurance,
achieving specific objectives by observing Good Manufacturing Practice.
● Policy ensures that products released for distribution are of the appropriate
quality.
● With such protocol in mind, a level of quality exists throughout the distribution
network so that authorized medicinal products are distributed without any
alteration.
● With this in mind we can acknowledge the intricacies of this practice and
demonstrate our complete understanding of parameters, required to be a
considered reliable and trustworthy resource for the transportation of
pharmaceutical products.
THE CAVALIER SEVEN PILLARS OF GDPSTABILITY
Storage
Temperature
Shipping
Temperature
Testing to
support
temperature
for
distribution
DISTRIBUTIONCONTROLMANAGEMENT
Qualification
Training
Premises &
Equipment
Material
Handling
Storage &
Inventory
Control
Transport
Product
Distribution
Protection
Exception
PERFORMANCEMANAGEMENT
Reporting
Metrics
Self
Inspection
Review
Meetings
Supply
Chain
Partner
Management
SELECTION
Quality Audit
Quality
Agreement
SOP
Continuous
Business
Review
QUALIFICATIONVALIDATION
Passive Ship
systems
Ambient
Temp
Profile
Active Ship
systems
Facility
Qualification
WMS
validation
Distribution
Validation
Plan
CONTINUOUSIMPROVEMENT
Industry
Regulatory
Validation
IMPORT&EXPORTCOMPLIANCE
Customs
Document
Control
Track &
Trace
CAVALIER BIOPHARMA & HEALTHCARE
LOGISTICS: PROCESS MANAGEMENT
● We assist with the
development and
implementation of complex
multi-country pharma logistics
solutions
● With infrastructure in place we
ensure and support
outstanding customer service
to our global customers at all
times
A group created to work toward and demonstrate core competencies
in Strategic Account Management.
CAVALIER CONCEPT:
THE KEY SUCCESS OF OUR PROGRAM
● Worldwide functionality
● A dedicated Cavalier Manager to
serve customer requirements
● A clearly defined and agreed-upon
process for customer development
and management
● A pro-active approach, with a
strategic focus on Client relationship
● Over 50 years of industry specific
expertise
● Leveraged by a value driven process
● Strong link to operational excellence
WHY CAVALIER?
● By reviewing best practice and
implementation of agreed upon
logistical solutions we add
significant value through:
› Thought Leadership
› Solution design and optimization
› Investment in tools and
techniques that provide
efficiencies of scale and savings
● The Supply Chain technology
we have invested in enables us
to provide to you a best in class
global service.
Cavalier Logistics enables our customers to concentrate upon their
day-to-day business and competencies.
CONTINUOUS PERFORMANCE MANAGEMENT
● Manage Customer Satisfaction
● Deliver Value through
Customer Focus
● Report Management
● Agreed KPI Review
● Continuous Process
Improvement
Cavalier Logistics offers customer-specific program management.
It is a globally integrated solution, designed to focus on the delivery of
critical information.
SUPPLY CHAIN METHODOLOGY
A call, email, online booking or fax
is received requesting a collection.
At this time we are given the pieces,
weight, dims, and final destination
The paperwork is received with the
full information including the
temperature requirements - HAWB
is updated. The booking is made
with the Preferred Airline AWB ETD
ETA & Cut-off at airline confirmed
The special temperature handing
instructions of the shipment is
noted on the MAWB. Export Alert is
sent to the local office that is
clearing the shipment. The export
alert includes: header, MAWB,
manifest, HAWB Invoice
On Green Light notification Driver
dispatched to Origin to pick up
shipment
Shipment tendered to the airline for
the flight prior to cut-off
1 hour after flight departure, a
check is done with the airline to
confirm shipment departed on
intended flight and shipment
departed as booked
Local office/partner confirms
arrival of shipment with the airline,
and any special handling/storage
instructions are being followed as
specified on the airline AWB
After customs clearance, the
shipment is collected from the
airline warehouse
Depending on cold chain
instructions, the shipment is either
returned to the destination office
for processing or delivered straight
away
Shipment sent out for delivery
LONG TERM PARTNERSHIP: COLLABORATION
● We know you expect the best
and we aim to please.
● We are proud to have earned a
reputation for being flexible to
our customer needs.
● We achieve this by listening to
and working with our customers.
● Open and trusting relationships
only strengthen the success of
such endeavors.
● Our goal is to develop flourishing
business relationships.
Our commitment is simple but focused - We firmly believe in healthy
partnership. We concentrate on competencies that enhance our ability to
be a competitive logistics provider.
CAVALIER : CONTACT INFORMATION
Stephen D. Winyard
e: swinyard@cavlog.com
t: +609 954 4409
Robbie Neilson
e: rneilson@cavlog.com
t: +703 733 4010
Clifford W. Wyllie
e: cwylllie@cavlog.com
t: +301 252 2222

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Cavalier Pharma Logistics Group Capabilities & IQP Overview winyard2015

  • 1. BIO PHARMA & HEALTHCARE DIVISION CAPABILITIES & IQP PARTNERSHIP
  • 2. CAVALIER PHARMA LOGISTICS VISION ● Cavalier Pharma-Logistics is a trusted and critical service provider to pharmaceutical companies engaged in the movement of pharmaceutical products. ● We excel in the global shipping of time and temperature-sensitive drugs, clinical trial supplies, vaccines and dangerous goods. ● Through our specialized services and attention to detail we provide unique customer specific solutions enabling our customers to have peace of mind and visibility to there supply chain and product while in our care.
  • 3. CAVALIER PHARMA LOGISTICS VISION ● To be a Global Service Provider of choice. ● Provide logistics competency to the pharmaceutical industry. ● Help our customers create and sustain a valuable advantage within their industry. ● To seek the ultimate goal of providing added value and mentoring long term business partnerships.
  • 4. WHAT IS DRIVING TODAY’S SUPPLY CHAIN, THE GLOBAL INDUSTRY TRENDS AND WHAT ARE THE GEOGRAPHICAL CHALLENGES? Cavalier offers a clear and precise strategy when handling your global clinical logistics. ● Our goal is to improve your supply chain efficiencies. ● Cavalier seeks and develops practices that minimize cost and risk. ● We understand Global Regulation and know how to deal with issues and processes around the world. ● Cavalier knows the critical requirements of being a good clinical supply chain partner.
  • 6. INTRODUCTION TO IQP The ORCA system has been introduced as a reusable logistics asset within the IQP certification scheme ● Offers GDP compliance ● World class temperature controlled distribution performance and operational simplicity. ● The Intelsius Qualified Partner (IQP) certification program provides a quality management framework that will enable you reuse the ORCA with assurance and maximize the performance of your logistics asset. ● The Qualified Intelsius Partner Program is designed to enable maximum performance from your ORCA systems every time. ● Giving our customers, confidence that their payload will arrive intact every time. ● A turn key cold chain solution delivers on time and at temperature !
  • 8. PROPOSITION TO THE MARKET • Traditionally packaging and logistics have been considered as separate purchases. • This has led Pharmaceutical companies controlling the packaging assets and then outsourcing the movement of the product. • In order to get the benefit of the higher performance and cost savings, the ORCA must be reused – this means someone has to take charge of tracking and managing the asset. • Pharmaceutical companies do not wish to do this, but it suits the core competencies of logistics companies.
  • 9. THE BENEFIT OF THE IQP Partnering in the IQP ,we can assuage any quality fears within pharmaceutical companies that are natural when outsourcing activities. • The IQP now offers a new solution to old problems. • The program offers benefit from economies of scale • By performing the process for multiple companies we gain benefits they cannot achieve individually.
  • 11. CAVALIER PACKAGING SOLUTIONS: TECHNOLOGY • Vacuum Insulation Technology (VIP) A vacuum insulated panel (VIP) is a form of thermal insulation consisting of a nearly gas-tight enclosure surrounding a rigid core, from which the air has been evacuated. • Advanced Plant-based Phase Change Material (PCM) A phase-change material (PCM) is a substance with high heat fusion which, melts and solidifies at a certain temperature, capable of storing and releasing large amounts of energy. Heat is absorbed or released when the material changes from solid to liquid and vice versa. • Thermochromic Labels Thermochromic is the property of substances to change colour due to a change in temperatures.
  • 12. CAVALIER PACKAGING SOLUTIONS: ADVANTAGES ● Outperforms the competition every time ● 2-8° C / CRT / -80° C available ● ISTA Certified Laboratory ● Qualified against all recognized thermal challenges ● Smart inventory ● Universal pack-out ● Thermo chromic Labels to show ready to use ● Packing instructions printed inside every lid ● 3D Barcode to get packing instructions through smart phone ● Reusable solution ● IATA Time & Temperature Label pre-printed
  • 13. CAVALIER PACKAGING SOLUTIONS: ADVANTAGES ● Outperforms the competition every time ● 2-8° C / CRT / -80° C available ● ISTA Certified Laboratory ● Qualified against all recognized thermal challenges ● Smart inventory ● Universal pack-out ● Thermo chromic Labels to show ready to use ● Packing instructions printed inside every lid ● 3D Barcode to get packing instructions through smart phone ● Reusable solution ● IATA Time & Temperature Label pre-printed
  • 14. BIO PHARMA HEALTHCARE SERVICE CENTER The cGMP storage and distribution facilities located in Maryland and Los Angeles are temperature controlled with Validated Controlled Ambient Temperature Storage (15°c – 30°c) of Scheduled Pharmaceuticals, Reagents, Life Science. • Validated -20 °c and -80 °c uprights. • Validated 2 °c to 8 °c & ambient storage • 43,000 square feet secure pharma grade facility. • A 100kVA natural gas generator provides redundant power. • Three kit assembly rooms for specific packaging. • Operating the facilities under cGMP guidelines, 21 CFR Parts 210-880 • Supported by audit ready SOPs for all processes. • The Maryland facility is licensed by the DEA for storage of Schedule 3-5 Pharmaceuticals. • Over 1,000 icage pallet positions.
  • 15. THE ● The Pharma Logistics Network has been established by industry professionals to meet the growing and recognized need for a truly professional Global Association of specialist forwarders where capability, resources, and infrastructure are in place to meet the most demanding client needs in the Pharmaceutical Industry with particular emphases on Bio Pharma Cold Chain requirements. ● There will be just one accredited and approved member in each major strategic location and beyond to ensure that the Pharmaceutical Industry has a truly independent, focused, and specialized core of Forwarding Companies that don’t just say “yes we can do this” but have the experience, dedication, and credentials to do the job and have met an exacting membership criteria.
  • 16. GLOBAL PLATFORM A consistent approach to cold chain distribution based upon a global platform
  • 17. CAVALIER PHARMA NETWORK: COLDCHAINLOGISTICS • Temperature Controlled Solutions • Multi use package lease • Clinical Trial Logistics • Pharma IT Platforms GLOBALCOMPETENCY • Cold Chain Services • Dedicated support teams • GxP Protocol and Process • Global Visibility WAREHOUSE • Regional Cold Chain facilities • Pharma Logistics trained experts • Pharma Grade Cold Storage GMP • Risk Management competencies • Global Footprint GLOBALFORWARDINGSPECIALIST • Pharma specific SOP library • Dedicated Process • Dedicated People • Data Device Option • Validated packing solutions A consistent approach to cold chain distribution based upon a global platform
  • 18. GOOD DISTRIBUTION PRACTICE (GDP) ● Applies to all drugs including active pharmaceutical ingredients, excipients, intermediates and finished goods. ● The pharmaceutical industry operates at a high level of quality assurance, achieving specific objectives by observing Good Manufacturing Practice. ● Policy ensures that products released for distribution are of the appropriate quality. ● With such protocol in mind, a level of quality exists throughout the distribution network so that authorized medicinal products are distributed without any alteration. ● With this in mind we can acknowledge the intricacies of this practice and demonstrate our complete understanding of parameters, required to be a considered reliable and trustworthy resource for the transportation of pharmaceutical products.
  • 19. THE CAVALIER SEVEN PILLARS OF GDPSTABILITY Storage Temperature Shipping Temperature Testing to support temperature for distribution DISTRIBUTIONCONTROLMANAGEMENT Qualification Training Premises & Equipment Material Handling Storage & Inventory Control Transport Product Distribution Protection Exception PERFORMANCEMANAGEMENT Reporting Metrics Self Inspection Review Meetings Supply Chain Partner Management SELECTION Quality Audit Quality Agreement SOP Continuous Business Review QUALIFICATIONVALIDATION Passive Ship systems Ambient Temp Profile Active Ship systems Facility Qualification WMS validation Distribution Validation Plan CONTINUOUSIMPROVEMENT Industry Regulatory Validation IMPORT&EXPORTCOMPLIANCE Customs Document Control Track & Trace
  • 20. CAVALIER BIOPHARMA & HEALTHCARE LOGISTICS: PROCESS MANAGEMENT ● We assist with the development and implementation of complex multi-country pharma logistics solutions ● With infrastructure in place we ensure and support outstanding customer service to our global customers at all times A group created to work toward and demonstrate core competencies in Strategic Account Management.
  • 21. CAVALIER CONCEPT: THE KEY SUCCESS OF OUR PROGRAM ● Worldwide functionality ● A dedicated Cavalier Manager to serve customer requirements ● A clearly defined and agreed-upon process for customer development and management ● A pro-active approach, with a strategic focus on Client relationship ● Over 50 years of industry specific expertise ● Leveraged by a value driven process ● Strong link to operational excellence
  • 22. WHY CAVALIER? ● By reviewing best practice and implementation of agreed upon logistical solutions we add significant value through: › Thought Leadership › Solution design and optimization › Investment in tools and techniques that provide efficiencies of scale and savings ● The Supply Chain technology we have invested in enables us to provide to you a best in class global service. Cavalier Logistics enables our customers to concentrate upon their day-to-day business and competencies.
  • 23. CONTINUOUS PERFORMANCE MANAGEMENT ● Manage Customer Satisfaction ● Deliver Value through Customer Focus ● Report Management ● Agreed KPI Review ● Continuous Process Improvement Cavalier Logistics offers customer-specific program management. It is a globally integrated solution, designed to focus on the delivery of critical information.
  • 24. SUPPLY CHAIN METHODOLOGY A call, email, online booking or fax is received requesting a collection. At this time we are given the pieces, weight, dims, and final destination The paperwork is received with the full information including the temperature requirements - HAWB is updated. The booking is made with the Preferred Airline AWB ETD ETA & Cut-off at airline confirmed The special temperature handing instructions of the shipment is noted on the MAWB. Export Alert is sent to the local office that is clearing the shipment. The export alert includes: header, MAWB, manifest, HAWB Invoice On Green Light notification Driver dispatched to Origin to pick up shipment Shipment tendered to the airline for the flight prior to cut-off 1 hour after flight departure, a check is done with the airline to confirm shipment departed on intended flight and shipment departed as booked Local office/partner confirms arrival of shipment with the airline, and any special handling/storage instructions are being followed as specified on the airline AWB After customs clearance, the shipment is collected from the airline warehouse Depending on cold chain instructions, the shipment is either returned to the destination office for processing or delivered straight away Shipment sent out for delivery
  • 25. LONG TERM PARTNERSHIP: COLLABORATION ● We know you expect the best and we aim to please. ● We are proud to have earned a reputation for being flexible to our customer needs. ● We achieve this by listening to and working with our customers. ● Open and trusting relationships only strengthen the success of such endeavors. ● Our goal is to develop flourishing business relationships. Our commitment is simple but focused - We firmly believe in healthy partnership. We concentrate on competencies that enhance our ability to be a competitive logistics provider.
  • 26. CAVALIER : CONTACT INFORMATION Stephen D. Winyard e: swinyard@cavlog.com t: +609 954 4409 Robbie Neilson e: rneilson@cavlog.com t: +703 733 4010 Clifford W. Wyllie e: cwylllie@cavlog.com t: +301 252 2222