Drug Product Development
ARx’s dedicated team guides branded and generic 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 collaborates 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:
- 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.
- CMC Document Support: Authorship of critical documentation including Formulation Development Report and Registration Reports to aid in product submission and approval.
- PMP-Certified Project Management: ARx project managers lead partners through the design control process, aligned with the appropriate regulatory filing path and critical milestones.