Focused expertise in softgel and lipid-based formulation
Douglas CDMO is a focused specialist in softgel scale‑up and lipid‑based formulation, delivering advanced formulation support and submission‑ready documentation aligned with major global regulatory requirements, including FDA and EMA.
Supported by an FDA‑approved, internationally recognised GMP facility, we enable efficient scale‑up and consistent commercial supply across multiple markets.
Specialists in lipophilic and low‑solubility molecules
Lipophilic APIs often present challenges in solubility, exposure, and reliable scale‑up. Softgel and lipid‑based formulations can offer an effective way to overcome these limitations.
Our expertise in softgel and lipid‑based formulation is designed to address these complexities, supported by strong process control and inspection‑ready quality.
Why consider softgels
Softgel dosage forms offer clear advantages for lipophilic and poorly soluble APIs, helping to improve performance, stability, and patient experience.
Improved bioavailability
Lipid-based fills enhance the absorption of poorly soluble drugs, supporting more consistent exposure and reducing the amount of API required compared to traditional solid dosage forms.
Enhanced stability
The sealed shell protects the formulation from air and moisture, helping preserve product integrity and extend shelf life.
Patient-friendly format
Softgels are smooth and easy to swallow, with strong patient preference supporting adherence and acceptance.
Safer manufacturing
Encapsulation reduces handling of the active ingredient during production, supporting safer manufacture of potent or sensitive compounds.
Lipid-based formulation expertise for complex APIs
Our capabilities span lipid‑based formulation development, softgel optimisation for lipophilic APIs, solubility enhancement strategies, and validated analytical and cleaning approaches, supported by globally aligned CMC documentation. Together, these enable formulations designed for reliable performance and regulatory readiness.
Reliable scale up, strong controls, and launch ready execution
We help keep complex formulations on track with predictable lipid‑based scale‑up, strong process controls, softgel and lipid expertise, transparent timelines, and reliable PPQ delivery.
Fast, structured tech transfer
Tech transfer is a critical stage for lipophilic products. Our structured, transparent approach supports a predictable transition and aligns with regulatory expectations.
We provide:
- Clear, well‑defined transfer frameworks
- Validated analytical and cleaning approaches
- Strong data‑integrity and documentation discipline
- Transfer packages aligned with FDA and EMA requirements
- A smooth progression into scale‑up and PPQ
The result is a reliable, low‑friction transfer into commercial‑ready manufacturing.
QMM-level quality and audit-ready documentation
Quality Management Maturity (QMM) is an FDA‑led initiative designed to evaluate and encourage advanced, proactive quality practices that go beyond basic CGMP requirements. Although still in its pilot phase, the program recognises organisations with strong quality culture, robust data‑integrity discipline, and consistent, reliable operational performance. Douglas was one of nine companies worldwide selected to participate in the FDA’s QMM pilot study.
Douglas CDMO supports lipid and softgel programs with:
- A mature QMS and proven inspection readiness
- Strong data‑integrity practices across development and scale‑up
- Audit‑ready documentation for global submissions
- Validation approaches suitable for lipid‑based and HPAPI systems
- Regulatory alignment for U.S., EU, and other regulated markets
Recognition and awards
The FDA’s Quality Management Maturity Pilot Study
In 2024, Douglas was one of nine companies worldwide selected to participate in the FDA’s QMM pilot study.