
Life Science Industry Services
Assuring project success across FDA and international medicinal health
agency regulated industries

PROJECT
MANAGEMENT
AM Life Science provides experienced master plan development and project management enabling successful project execution.
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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.
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ENGINEERING
SERVICES
We support engineering efforts of construction completion, equipment start-up, commissioning and operational readiness, process optimization and manufacturing support.
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CLEANING
DEVELOPMENT
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.
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CONSTRUCTION
QUALITY
We have the expertise to bridge between the design, construction, quality release, commissioning and qualification. Our approach is to deploy quality by design (QbD) methods throughout the construction process.
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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...
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...
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...