Douglas CDMO delivers FDA‑ready quality frameworks, regulatory‑aligned documentation, and disciplined operational controls that support softgel and lipid‑based programs entering U.S. and EU markets.
Our approach combines mature quality systems, clear governance, and fully traceable processes to ensure every stage of development is reliable, compliant, and inspection‑ready.
QMM‑recognised quality maturity
Douglas was selected by the FDA as one of only a small number of pharmaceutical companies to participate in the Quality Management Maturity (QMM) pilot, an initiative designed to recognise organisations with advanced, proactive quality systems. This selection highlights Douglas’s companywide commitment to quality and continuous improvement.
Regulatory‑grade CMC packages for U.S. and EU submissions
Douglas CDMO prepares submission‑ready CMC documentation that clearly communicates formulation rationale, analytical validation, cleaning strategy, control frameworks, and stability approaches. Our structure and clarity help reduce regulatory questions and keep approval pathways on track.
Our Regulatory team delivers:
- CMC packages aligned to FDA and EU requirements
- Documentation supporting softgel and lipid‑based systems
- Clear justification of process design and controls
- Audit‑ready data packages for regulated markets
Reliable scale‑up and predictable PPQ for softgels
Douglas combines technical depth in lipid‑based systems with disciplined process control to support predictable PPQ and smooth commercial transition. Our teams understand the nuances of softgel and HPAPI processing, enabling robust scale‑up that withstands regulatory scrutiny.
Quality systems aligned to global regulatory expectations
Douglas CDMO is structured to support innovators targeting U.S., EU, and other regulated markets. From quality systems through to documentation, scale‑up, and PPQ, our focus is on providing clarity, consistency, and regulatory confidence across the full lifecycle of softgel and lipid‑based products.
You gain:
- FDA‑aligned quality systems
- Mature QMS foundations
- Submission‑ready documentation
- Strong data‑integrity practices
- Reliable softgel PPQ and scale‑up
- A partner built for regulated markets
Recognition and awards
The FDA’s Quality Management Maturity Pilot Study
In 2024, Douglas was one of only nine companies selected globally to participate in this ongoing, in-depth review of our processes that contribute to our ability to deliver the right quality products on time.