PARTNERING FOR SUCCESS

Transcription

PARTNERING FOR SUCCESS
A DPT COMPANY
PART N ER I N G F O R S UCCE S S
WHO WE A RE
Confab is a contract development and manufacturing organization (CDMO) located in Saint-Hubert, Quebec,
Canada with a specialized focus on solid, semi-solid and liquid dosage forms. Over the past 30+ years, we have
continued to invest and expand our infrastructure and capabilities at our world-class cGMP facility.
Confab’s 350 employees have unmatched levels of expertise which contributes to the company’s outstanding
regulatory history. You can count on us to get your product to market faster and easier by providing flexible and
value added manufacturing solutions.
As a leading CDMO we aim to develop partnerships with our clients in order to guarantee the industry’s highest
standards of pharmaceutical products.
Our 140,000 sq. ft. facility is one of the most respected cGMP compliant facilities in Canada. In addition to
being licensed by Health Canada Therapeutic Products Directorate, our facility has been inspected, accepted
and licensed by the U.S. Food and Drug Administration (FDA), Anvisa and other international markets.
RESEARCH & D E V E LO P M E N T
Confab provides comprehensive pharmaceutical research and development
services focused on immediate and sustained release solid, semi-solid and
liquid dosage forms. Our scientists combine decades of pharmaceutical
formulation development expertise with leading-edge technologies to provide
the best solutions to our customers’ needs.
Confab offers manufacturing capabilities with expertise in product
development, technical transfers, and scale up. We manufacture a wide
range of products across multiple dosage forms and world-wide distribution.
P HA RMA CE UTICA L R E S E A R C H &
DE V E LOP ME NT S E RV I C E S
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Pre-formulation / Formulation
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Technical Transfers
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Process Development / Validation
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Stability Studies
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Clinical Trial Manufacturing
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Analytical
COMME RCI A L OP E RAT I ONS
At Confab we combine infrastructure with teams of scientists who have an
in-depth understanding of solids, semi-solids and liquids that is backed by
decades of experience. It is this combination of people and infrastructure
that sets us apart from other CDMOs.
SOLID MANUFACTURING CAPABILITIES:
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Powder Blending
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Standard Granulation
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High Shear Granulation
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Powder Compaction
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Tableting
Our focus and market activities are in Canada and the United States.
However, we also serve companies that market their products in South
America, Europe and Asia.
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Tablet Coating
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Encapsulation •
Double Encapsulation
Confab offers a wide variety of manufacturing capabilities including: core
centered tableting, tablet dry coating, granulation, tablets and hard shell
capsules, several types of coating, creams, gels, ointments, nasal sprays,
syrups, suspensions, liquids and suppositories.
•
Tablet Printing
We manufacture different categories of products including: Natural
Products (NPN), Over-the-Counter drugs (OTCs), Drug Identification
Number (DIN) products, New Drug Applications (NDA), Abbreviated New
Drug Applications (ANDA), Veterinary Products, Narcotics and Controlled
Substances with a level 10 security vault.
LIQUID MANUFACTURING CAPABILITIES:
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Liquid Solutions and Suspensions
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Gels and Lotions
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Pastes, Creams and Ointments
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Suppositories
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Syrups
SOL I D AND LIQ U ID PA C K A G IN G
CAPABI LI T I E S
Product development and manufacturing are only a part of the services we
provide Confab’s clients. We view packaging as integral to our formula to help
you become successful. Confab’s pharmaceutical packaging services will help
you identify the best drug packaging for your complex solid dose, semi-solid
creams and suppositories and liquid products.
•
Blistering Operations: thermo formable
film and cold form (continuous
motion)
•
New high speed tablet counter,
capsules and soft gels bottling
operations
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Semi-solid filling line (cream and
ointment)
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Suppositories – plastic & aluminum
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Metal and plastic tube filling
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Gel filling
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Fully integrated liquid bottling line with
automated cartonning and automated
quality inspection
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Non-sterile drinkable plastic ampoules
for oral use
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Nasal spray filling, laminar flow hood
(nasal solutions)
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Manual kit assembly for samples or
commercial products
QUA L I T Y
Our quality staff provides oversight of GMP compliance by administering
quality systems such as Corrective Action and Preventive Action (CAPA),
complaints, Annual Product Review (APR), deviation investigations, training,
stability testing and internal audit programs.
On a monthly basis, key compliance and quality indicators are utilized
to ensure continuous compliance of our organization and are presented
to upper management. We measure adherence to inspection and audit
commitments. By doing this, Confab ensures a continuous improvement of
existing quality systems to strive for success of our customers.
C O N T I N U O U S I MP R O V E ME N T
Enterprise-wide Operational Excellence
• Inventory management
• Planning systems
• Packaging operations
• Visual management tools
COMPLI ANCE
Our outstanding regulatory compliance history serves as a strong foundation
for our organization. Our management team has years of experience in
pharmaceutical manufacturing for international markets.
We provide oversight of regulatory compliance by administering an effective
internal audit program. We also provide support for regulatory and client
inspections and vendor auditing activities.
A comprehensive set of standard operating procedures guides all key
activities and keeps us compliant with regulations from U.S. Food and Drug
Administration (FDA), Health Canada, European Medicines Agency (EMA),
Customs Trade Partnership Against Terrorism (CTPAT), narcotic license,
precursor license, and site license for dietary supplement and foreign
markets.
Our focus on continuous training and investment in quality systems helps
ensure that products developed and manufactured at Confab meet the
highest quality standards.
A CCRE DITATIONS & C O M P L I A N C E
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Health Canada Establishment License
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FDA
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Mutual recognition with EMEA
countries
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ANVISA
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Other countries
CA L L US T O DI S CUS S HOW CONFA B CA N BE
Y OUR PA RT NE R F OR S UCCE S S
1.888.826.6322
A DPT COMPANY
Confab
4355 Sir Wilfrid Laurier Blvd.
Saint-Hubert, QC, Canada J3Y 3X3
888.826.6322
450.443.6666
www.confab.com