New Zealand based, Douglas CDMO specialises in GMP softgel and HPAPI softgel development with validated scale‑up, reliable tech transfer, and global‑ready documentation.
GMP softgels. Predictable scale‑Up. U.S./EU‑ready quality.
For Australian innovators aiming for regulated markets, Douglas CDMO delivers compliant, reliable softgel manufacturing built to global expectations.
From complex formulations to high‑potency programs, we provide clear CMC pathways and inspection‑ready execution.
Clinical ready and commercial ready softgels
We support full softgel development including:
- GMP softgel manufacturing
- Rx and OTC softgels for Australia
- HPAPI softgels for AU, U.S., and EU markets
- Validated softgel scale up
- Softgel PPQ with predictable timelines
- Clear, global ready CMC documentation
Our specialised softgel capability, experienced team, and disciplined onboarding approach help keep your program moving without unnecessary stalls. You gain regulatory confidence, fast transfer, and reliable performance for U.S. and EU submissions.
Deep expertise in lipophilic APIs and lipid‑based softgels
Douglas CDMO works extensively with challenging BCS II/IV APIs and lipid‑based delivery systems.
Lipophilic APIs perform best in softgel and lipid‑based systems designed to support exposure, stability, and global submission requirements.
Our lipid softgel services include:
- Lipid‑based formulation development
- Lipophilic softgel optimisation
- BCS II/IV solubility‑enhancement strategies
- Validated lipid‑based scale‑up and cleaning
- Documentation and CMC clarity for global submissions
Fast, structured, and predictable softgel transfer
Douglas CDMO delivers a tech transfer process that is predictable, transparent, and aligned with regulatory expectations.
We deliver:
- Structured softgel tech transfer frameworks
- Validated methods and cleaning procedures
- U.S./EU‑ready CMC documentation
- Softgel processes aligned to global expectations
- Reliable PPQ execution without delays
High Potency softgels with strong containment and validation
We have more than 30 years of experience working with high‑potency small‑molecule formulations and have supported multiple successful registrations. Our facilities, controls, and procedures are designed to safely handle light‑sensitive retinoids, hormones, cytotoxics, and immunosuppressants, particularly in liquid and softgel dosage forms.
We also have a strong track record in developing and supplying pharmaceutical softgel products for the United States and European markets, supported by clear, regulatory‑grade documentation and alignment with U.S. and EU submission requirements.
Quality led manufacturing with clear documentation
Douglas CDMO supports Australian teams with:
- Inspection‑ready quality systems
- Inspection‑ready PPQ
- Global‑ready CMC packages
- Strong QMS and predictable timelines
- Validation aligned to U.S., EU and other 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.