Life Science Industry Services
Assuring project success across FDA and international medicinal health
agency regulated industries
AM Life Science provides experienced master plan development and project management enabling successful project execution.Learn more
CQV / PV
AM Life Science provides the knowledge and practical experience to develop and implement a custom tailored Commissioning, Qualification, Validation (CQV) and Process Validation (PV) program for your specific needs.Learn more
We support engineering efforts of construction completion, equipment start-up, commissioning and operational readiness, process optimization and manufacturing support.Learn more
AM Life Science is an invaluable resource in your cleaning development program, including authoring, training and executing Clean In Place (CIP), Clean Out of Place (COP) and Steam In Place (SIP) protocols.Learn more
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...
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...
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...