Pharmaceutical News & Resources

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

March 20th, 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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Posted in: Outsourced Pharma

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

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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Posted in: Pharmaceutical Online

XTALKS PRESS RELEASE FOR Nitto Avecia Pharma (April 17/18 Webinar)

April 17th, 2018 by aveciapharma

HEADLINE Cell-Based Assays in a CGMP Environment: Approaches for Clinical and Commercial Stability Studies, New Webinar Hosted by Xtalks. SUB-HEADLINE Presentation to highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP and ) and...

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Posted in: Press Release


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