Contract manufacturing organizations (CMOs) and contract research organizations (CROs). Global sourcing of pharma ingredients and services. Trends and challenges for the biopharmaceutical and pharmaceutical industries.
April 25, 2013
By:
DPT Laboratories
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA?s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. While both sponsor companies and service providers must adhere to robust quality standards and undergo regular regulatory inspections, manufacturers are ultimately held responsible by regulatory agencies when it comes to adhering to cGMPs.
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April 25, 2013
By:
Anne Russell, Charles River
This study assesses the suitability of the Biotyper platform for identifying environmental isolates, demonstrates our systematic approach to broaden the reference library and shows the impact of adding new library entries on reportability for this industrial sector.
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May 2, 2013
By:
Eric Langer
Pharmaceutical Technology
Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.
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April 2, 2013
By:
Jim Miller
Pharmaceutical Technology
Eisai and Biogen Idec pursue an innovative approach to capacity management.
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March 2, 2013
By:
David Elder
Pharmaceutical Technology
FDA's requirements for API manufacturers in regards to ICH Q7.
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March 2, 2013
By:
Patricia Van Arnum
Pharmaceutical Technology
As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.
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February 2, 2013
By:
Jim Miller
Pharmaceutical Technology
Is the contract-only CMO an endangered species?
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February 1, 2013
By:
Eric Langer
Pharmaceutical Technology
Innovation resulting in improved productivity continues unabated and is a primary driver for many of the current biopharmaceutical trends.
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February 1, 2013
By:
Patricia Van Arnum
Pharmaceutical Technology
In the arena of pharmaceutical outsourcing, when speaking of partnerships, the discussion typically focuses on the relationship between a pharmaceutical/biopharmaceutical company as the sponsor company and a contract-service provider.
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