March 5th, 2019 by aveciapharma
Nitto Avecia Pharma Services is a FDA inspected cGMP contract development and manufacturing organization supporting the pharmaceutical and biopharmaceutical industries from early phase through post-market life cycle management. With a state-of-the-art facility, experienced staff, and robust quality...
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Tags: FDA, parenteral manufacturing, GMP environment
Posted in: Pharmaceutical Online
February 14th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Nitto Avecia Pharma Services
Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry,...
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Tags: presentations, case studies, Xtalks, FDA, parenteral manufacturing
Posted in: Pharmaceutical Online
