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Apr 15 2019

AMLS Provides QbD Solution for Gene Therapy Renovation Project

AM Life Science (AMLS) recently partnered with a Boston-area gene therapy company to insert a Commissioning Qualification and Validation (CQV) subject matter expert (SME) at the pre-construction/construction phase of the facility design/build...

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Mar 11 2019

AMLS Completes Upgrade of Engineering & CQV Lifecycle Program

AM Life Sciences (AMLS) has completed and turned over work for upgrades to a New England pharmaceutical company’s Engineering and Commissioning, Qualification, and Validation (CQV) Lifecycle program for equipment and systems. AMLS...

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Feb 11 2019

AMLS Introduces Our “Quality by Design” Approach to Biotech Project

AM Life Science (AMLS) promotes an approach to quality by design (QbD) that we call Early Quality Integration (EQI). The goal of this process is to better support biotechnology companies meet FDA...

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Oct 3 2018

Quality by Design for FDA Approval: Building Control vs. Inspection

In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward...

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Oct 1 2018

Quality by Design for FDA Approval: Building Control vs. Inspection

In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward...

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