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.
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
ENGINEERING
SERVICES
We support engineering efforts of construction completion, equipment start-up, commissioning and operational readiness, process optimization and manufacturing support.
Learn more
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.
Learn more
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.
Learn moreRecent News
Sep
10
2018
Quality by Design (QbD) in the Pharmaceutical Industry
Quality by design (QbD) is often associated with construction projects. The idea is to develop processes that support quality throughout the construction project from planning to building to operations. In the pharmaceutical...
Aug
15
2018
The USP 61 and USP 62 Updates You Need to Know
In 2009, the United States Pharmacopeia (USP) issued harmonized reference standards for the Microbiological Examination of Non-Sterile Products. While AM Life Science (AMLS) does not offer services that directly support method validation...
Jun
18
2018
The CQV Process: Where to Get Started
CQV (Commissioning, Qualification, and Validation) is a very detail-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment/systems into use. Additionally, with FDA regulations and requirements...