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Category Archives: agreement

Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement

In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…

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Inside Look: The Role of the IPR Department

Intellectual Property Rights and its Importance in Research, Business & Industry We wrote a post on the patent cliff issue back in 2015. The patent cliff has served to further…

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Defining the Contract Pharma Provider Relationship

I read an article at Pharmaceutical Manufacturing earlier this year (Inking the Deal: Mastering the art of lasting outsourcing relationships in the pharmaceutical industry) on the nature of contract pharma…

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Successful Pharma Partnering: Managing the CMO Relationship

With everything involved in bringing a drug to market, enlisting the services of an experienced CMO can prove to be a very worthy investment. Ideally, the relationship between a pharma…

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Intellectual Property Management Group Focuses on API Innovation and Differentiation for Customers

With potential projected losses of $16-32 billion for drugs going off-patent in 2015, intellectual property (IP) is increasingly crucial to keeping a competitive edge in the pharmaceutical and biotechnology markets….

Posted in agreement, API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CRO/CMO, Freedom to Operate, IP, Patent, R&D, technology transfer | Comments Off on Intellectual Property Management Group Focuses on API Innovation and Differentiation for Customers

APIs, Quality Agreements and the Partner-or-Supplier Debate.

It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.  The consensus seems to be that the FDA shifted the responsibility…

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The Contract Manufacturing & Intellectual Property Challenge: Solution? Don’t Compete With the Customer.

Intellectual property rights have always been integral to negotiations for pharmaceutical contract manufacturing services, but growing complexities surrounding global IP issues, complex science, inevitable process improvements, IT infrastructure & security,…

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Manufacturing Collaboration with Mitsubishi Healthcare Unit API Corporation

Some exciting news for Neuland Labs this week: we’ve just entered into a manufacturing collaboration with Tokyo-based API Corporation (APIC) – a healthcare unit of Mitsubishi Chemical Holdings Group. As…

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