Quality & Compliance
Our superior quality and compliance history with authorities like FDA, EMA, ANVISA, and DEA means your product is in good hands
All our pharmaceutical development and manufacturing services are built for quality and proven by performance.
Quality is more than a department; it’s embedded in everything we do. From early design through commercial manufacturing, we think ahead to build quality into our systems, designs, formulations, processes, and analytical methods. Each stage of development, from R&D to commercial, has a phase appropriate level of control under our comprehensive Quality Management System to ensure that your product is made, and documented, right.
We know you need a partner you can trust to deliver safe, effective, and compliant product as well as complete, accurate and clear documentation without surprises or delays. That’s why we focus on reliability, quality, and regulatory excellence.
On this page
Regulatory Compliance without Compromise
We have a long track record of successful inspections and regulatory submissions. Our facilities and quality systems are regularly inspected by:
- Healthcare Authorities (e.g. US FDA, EMA, ANVISA)
- DEA (Schedules I-V)
- State Boards of Pharmacy
- Clients
We operate with integrity, transparency, and a readiness mindset so that inspections go smoothly.
Comprehensive Quality Systems
Our compliance history is excellent because our QMS is designed and proactively maintained to support the full lifecycle of small molecule drug development and manufacturing. We have phase-appropriate controls for clinical programs and robust quality requirements for late-phase and marketed products.
Key features include:
- Document and change control
- Deviation, OOS, nonconformance, and CAPA management and trending
- Quality risk management
- Training and qualification systems
- Internal and external audit readiness
- Supplier qualification and oversight
- Equipment maintenance, calibration, and validation
- Process and Method Validation
- Process tracking and trending
Our quality teams are present and up to date with all our cGMP activities, allowing us to identify and address risks proactively, ensure data integrity, and respond quickly to evolving situations.
Proven Reliability
We pride ourselves on our ability to deliver what we promise, and we track on-time, in-full (OTIF) delivery rate for all of our clinical and commercial programs. Our culture of accountability and cross-functional alignment ensures your product moves forward on schedule and with clear communication at every stage.
Design • Develop • Manufacture
Let's build something remarkable