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 • Pre-formulation / Formulation • Technical Transfers • Process Development / Validation • Stability Studies • Clinical Trial Manufacturing • 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: • Powder Blending • Standard Granulation • High Shear Granulation • Powder Compaction • 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. • Tablet Coating • 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: • Liquid Solutions and Suspensions • Gels and Lotions • Pastes, Creams and Ointments • Suppositories • 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 • Semi-solid filling line (cream and ointment) • Suppositories – plastic & aluminum • Metal and plastic tube filling • Gel filling • Fully integrated liquid bottling line with automated cartonning and automated quality inspection • Non-sterile drinkable plastic ampoules for oral use • Nasal spray filling, laminar flow hood (nasal solutions) • 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 • Health Canada Establishment License • FDA • Mutual recognition with EMEA countries • ANVISA • 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