ARx Product Development

As a comprehensive partner in product development, ARx, LLC supports the submission of drug products beyond formulation and manufacturing. Our project management team works collaboratively with each customer throughout the product design control process to properly manage all chemistry, manufacturing and controls CMC regulatory filing elements. By leveraging partnerships with industry experts and continuously expanding our in-house capabilities, the ARx team guides each stage of a project with expertise in the critical attributes of each dosage form.

At ARx we support our global partnerships with the following project capabilities:

 

Project Capabilities
Phase I & II Clinical Production On-site, clinical manufacturing lab provides cGMP individually packaged units for animal or pilot-scale clinical studies.
Excipient Procurement & Qualification Sourcing of pharmaceutical-grade excipients and qualification in accordance with client and agency requirements.
Analytical Method Development & Validation Analytical testing and support capabilities for method development, transfer, verification, validation, and final product release.
Stability Study Management Management of chamber set-up, storage, pulls, and testing in support of specific filing requirements.
Bulk Hold Stability Studies Characterization of liquid blend and bulk intermediate roll stock for optimal shelf life and storage conditions.
PMP-Certified Project Management ARx project managers lead partners through the design control process, aligned with the appropriate regulatory filing path and critical milestones.