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Category Archives: Quality Agreement

Neuland & Regulatory Excellence

With more than 650 regulatory filings to date, Neuland is committed to total compliance and regulatory excellence. In fact, we consider it our core competency: the application of strong process…

Posted in APIs, audit, award, Capabilities, CDMO, Contract Manufacturing, FDA, Neuland Labs, QA/QC, Quality, Quality Agreement, regulatory, Uncategorized | Comments Off on Neuland & Regulatory Excellence

Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

Neuland has recently welcomed the addition of a new, dedicated Process Engineering Lab to its R&D Center. The lab opened in March, and supports operations and safety studies via a…

Posted in Chemistry, CMC, Contract Manufacturing, drugs, method development, Neuland Labs, process chemistry, Process Engineering, QbD, Quality, Quality Agreement, R&D, Route Design, scale-up, synthesis | Comments Off on Unveiling Neuland’s Process Engineering Lab: Tightening our Focus on QbD

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It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.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…

Posted in agreement, APIs, change orders, Contract Manufacturing, CRO/CMO, FDA, ICH, method development, Project Management, Quality Agreement | Comments Off on APIs, Quality Agreements and the Partner-or-Supplier Debate.