cavalier bio pharma brochure

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CAVALIER LOGISTICS DULLES/WASHINGTON D.C., 45085 OLD OX ROAD, DULLES, VA 20166 PHONE: +1 (703) 733-4010 | WWW.CAVLOG.COM “Turn Key Cold Chain Solutions on Time at Temperature”

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Page 1: Cavalier Bio Pharma Brochure

CAVALIER LOGISTICS DULLES/WASHINGTON D.C., 45085 OLD OX ROAD, DULLES, VA 20166 PHONE: +1 (703) 733-4010 | WWW.CAVLOG.COM “Turn Key Cold Chain Solutions on Time at Temperature”

Page 2: Cavalier Bio Pharma Brochure

Best in classOur team includes dedicated customer service professionals whose goal is to create on-going relationships by providing reliable logistical solutions. We are characterized by our technology, assets, reliability, innovation and efficiency.

Cavalier Logistics, BioPharma and Healthcare Services Division offers a clear and precise strategy when handling your global clinical logistics. Our goal is to improve your supply chain efficiencies by:

• Seeking and developing practices that minimize cost and risk

• Understanding global regulations to deal with global issues and processes

• Knowing the critical requirements of being a good clinical supply chain partner

It is through our complete understanding of these challenges that your dedicated Cavalier Logistics, BioPharma and Healthcare Services Team is best-equipped to provide a superior service offering.

Cavalier Logistics, BioPharma and Healthcare Services Division is a trusted and critical service provider for companies engaged in the movements of pharmaceutical products. We are experts in the global shipping of time and temperature-sensitive drugs, clinical trial supplies, vaccines and dangerous goods.

We assist with the development and implementation of complex multi-country pharma logistics solutions and have the infrastructure in place to ensure and support outstanding customer service to our global customers at all times. Through our specialized services and attention-to-detail, we provide our customers with bespoke cold chain solutions that offer both peace of mind and visibility.

Specializing in controlled-temperature logistics

We achieve our high quality standards by consistently delivering on our promise of a robust, reliable and cost effective cold chain solution to fit individual requirements.

Page 3: Cavalier Bio Pharma Brochure

Gateway cold chain competence centers We provide a network of four dedicated operational facilities, strategically located in New York, Washington DC, Chicago and Los Angeles designed specifically for the Life Science market. Furthermore, highly trained healthcare dedicated staff and standardized excellence processes will provide the high quality level our customers require. In addition, we will provide the necessary technical infrastructure to monitor and control the product flow and offer customized services that encompass:

• US customs brokerage

• FDA - USDA expertise

• Gateway storage and replenishment -80 °C to CRT

• Appropriate storage conditions during the import / export process

• Pre-conditioning stations for passive and active solution sets

• TSA approved screening capability with particular approval to the Pharma Industry

From origin to destination, we make it happenFounded in 1985, Cavalier Logistics offers full turn-key regional, national and international logistics services and is proud of our excellent reputation for providing outstanding services. Our established quality control procedures exceed industry standards allowing us to provide each and every customer with the most reliable and dedicated service it deserves.

A consistent approach to cold chain distribution based upon a global platform

The Pharma Logistics Network was founded by Cavalier Logistics to establish a platform of industry professionals to meet the growing and recognized need for a truly professional Global Association of specialist forwarders.

A validated capability, resources, and infrastructure in place to meet the most demanding client needs in the Pharmaceutical Industry Cold Chain requirements.

Page 4: Cavalier Bio Pharma Brochure

The Cavalier Seven Pillars of GDPIndustry

Regulatory

Validation

CO

NTIN

UOUS

IMPR

OVE

MEN

T

Storage Temperature

Shipping Temperature

Testing to support temperature for distribution

STAB

ILITY Qualification

Training

Premises & Equipment

Material Handling

Storage & Inventory Control

Transport

Product Distribution

Protection

Exception

DIS

TRIB

UTIO

N C

ON

TRO

L M

ANAG

EMEN

T

Reporting Metrics

Self Inspection

Review Meetings

Supply Chain Partner Management

PERF

ORM

ANC

E M

ANAG

EMEN

T

Reporting Metrics

Self Inspection

Review Meetings

Supply Chain Partner Management

SELE

CTIO

N Passive Ship Systems

Ambient Temp Profile

Active Ship Systems

Facility Qualification

WMS Validation

Distribution Validation PlanQ

UALI

FIC

ATIO

N V

ALID

ATIO

N Customs

Document Control

Track & Trace

IMPO

RT &

EXP

ORT

CO

MPL

IAN

CE

The advantages of our comprehensive range of reusable temperature-controlled packaging solutions include:

• 2-8 °C / CRT / -80 °C available

• ISTA Certified laboratory

• Qualified against all recognized thermal challenges

• Smart inventory

• Universal pack-out

• Thermochromic 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

A solution to meet your needsWe are also well versed within the parameters of Good Distribution Practice (GDP). This commonly referenced industry best practice standard has gained regulatory acceptance in the EU, Japan and the United States.

Most clinical products travel thousands of miles over extended periods of time before arriving at their origin. We believe the best strategy to ensure compliancy, reduce the risk of temperature excursions, handling mishaps and documentation errors within the pharmaceutical supply chain is to engage a single supplier to manage the full process from packaging required, international transport, storage and distribution.

Selecting a single service provider enables:

• Elimination of miscommunication, technical errors and conflicting SOPs

• Maximum control and a clear chain of custody at all points during transit

• Delivery of increased reliability, control and accountability in complex requirements

• A single point of contact

• Significant cost savings from cost of service and the elimination of potential product loss due to mishandling

Safe and secureThe pharmaceutical industry operates at a high level of quality assurance, achieving specific objectives by observing Good Manufacturing Practice (GMP). It is our complete understanding of these parameters that enables us to be a reliable and trustworthy resource for the transportation of pharmaceutical products.

Our state-of-the-art, cGMP storage and distribution facilities are validated temperature-controlled storage for scheduled pharmaceuticals, reagents and life sciences products.

The features and services of our controlled environment facilities include:

• Validated -20 °C through -80 °C uprights

• Validated 2 °C to 8 °C and ambient storage

• Validated 15 °C to 30 °C ambient storage

• 100kVA natural gas generators for redundant power

• Secure pharma grade facility

• Assembly rooms for specific packaging requirements

• Operating the facilities under cGMP guidelines and 21 CFR Parts 210-880

• Supported by audit ready SOPs for all processes

• Licensed by the DEA for storage of schedule 3-5 pharmaceuticals

We also provide temperature monitoring services that give you the reassurance of knowing your product’s integrity is never compromised.

Our unique technology gives you quick access to temperature data for your product in transit or in storage.

Accreditation and validation Cavalier Logistics, BioPharma and Healthcare Services Division is a forward-thinking and pioneering company. We have the capability, resources and infrastructure in place to meet the most demanding needs of the pharmaceutical industry with particular emphasis on BioPharma cold chain requirements.

Cavalier Logistics, BioPharma and Healthcare Services Division is also an Intelsius Qualified Partner (IQP).

By being part of this certification program, we are able to address the issues of asset management and quality which have prevented temperature-controlled packaging re-use in the past.

Through IQP certification we provide our customers with a quality management framework that facilitates the re-use of a temperature-controlled packaging solution.

We take charge of the tracking and management of our customer’s assets. This enables us to maximize performance through re-use and provide assurance that the payload will arrive intact and at temperature every time.