“As regulatory agencies across the globe increase their requirements for integrity testing of sterile package systems, and as our client base continues to grow in Europe, it makes expansion of this and other analytical services our next logical step,” Mark Stier, head of analytical services at AMRI told Outsourcing-Pharma.com.
Stier said the move was fueled by a preference expressed by clients wanting to work closer to their own time zone for analytical testing.
“Having research centers located in and near major markets – along with the capacity to move work around globally – provides the greatest opportunity to meet our customers’ needs,” he said.
“Local clients who do not want to ship their products to the United States will be able to keep them within Europe, an option which may not have been available previously.”
The global contract research, development and manufacturing organization (CDMO) plans to build custom laboratory space for the CCIT services in its analytical facility in Valladolid, Spain, at which it recently added a new multipurpose aseptic API line.
Additional analytical services will be added at the site later in the year, including reference standard and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability facilities, according to AMRI.
In October 2017, the company announced it would be offerings its impurity solutions as a stand-alone service in response to new regulatory requirements that set limits for the amounts of elemental impurities in drug products.