The Top Strategic Objective: Exceptional Quality
As a contract pharmaceutical manufacturer, we know that the need for quality products and patient safety is critical. We deliver exceptional quality by hiring smart, accountable employees and training them to bring the highest regard for quality into every aspect of their work – including our processes, results, and relationships.
Measure Success
We have established key metrics that focus on quality throughout the product life cycle and robust quality systems for validation, document management, quality control and batch release. These systems are continuously audited internally as well as by clients and regulatory agencies.
By working collaboratively with the FDA and partnering with organizations similarly aligned around quality-focused cultures, we ensure that continued cGMP compliance reflects long-term consistency and reliability. Our relationships center around trust and precise execution.
Protect Your Reputation
As a forward-thinking aseptic contract manufacturing organization, we stay ahead of current and future regulatory challenges. Our detail-oriented workforce maintains a validated, 21 CFR Part 11 compliant electronic quality management system to manage our training, controlled document, change control, non-conformance, and CAPA programs. We perform testing in accordance with USP/NF and EP methodologies and monographs in addition to client-specific methods. We have also validated all analytical equipment that uses software to collect and analyze data for full compliance with 21 CFR Part 11.
Deliver The Highest Quality Products
From formulation development to commercialization, we ensure consistent delivery of the highest quality products by providing clients with state-of-the-art facilities, cutting-edge technology, and best-in-class equipment specifically designed to evolve with the ever-changing regulatory landscape and the growing pharmaceutical market.
We offer microbial and analytical testing services for raw materials, components, in-process compounds, finished goods, and stability samples. Our analytical capabilities include endotoxin testing, bioburden, microbial limits, particulate, pH, TOC, GC, FTIR HPLC, Karl Fischer, UV-Vis, and various wet chemistry tests.