Elemental Impurities Emerge As New Compliance Challenge

March 13th, 2019 by aveciapharma

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? After almost 20 years of discussion, the FDA issued new guidelines in 2018 for controlling and measuring the risk of contamination within pharmaceutical products due to the presence...

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Posted in: BioProcess Online, Outsourced Pharma

Nitto Avecia Pharma Services Parenteral Manufacturing

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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Posted in: Pharmaceutical Online

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

February 14th, 2019 by aveciapharma

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

Container/Closure Innovation Delivers New Complexity In Drug Quality

February 5th, 2019 by aveciapharma

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? Many new delivery systems and drug-device combinations make dosing less cumbersome for patients and healthcare providers. But they add more complexity for drug developers....

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Posted in: Pharmaceutical Online


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