Move smoothly from development into PPQ and commercial supply with a transfer process that’s validated, well‑documented, and inspection‑ready. Be guided by a team that keeps you informed every step of the way and keeps your project moving.
Why Teams Choose Douglas CDMO
Softgel programs lose momentum when transfer, validation, or documentation fall behind. Our specialised softgel capability, experienced team, and disciplined onboarding approach help keep your program moving without unnecessary stalls.
- A validation‑led approach from the start
Method transfer, verification, and cleaning validation built to support lipid, lipophilic, and HPAPI programs, aligned to global expectations.
- Predictable PPQ
Clear ranges, strong process control, and robust batch records designed for a smooth path into PPQ and commercial readiness.
- Submission aligned documentation
CMC and PPQ packages structured for US and EU submissions, built to withstand regulatory review.
What we deliver
- Softgel tech transfer and scale‑up from late development into PPQ and commercial supply
- Fast, structured onboarding that removes uncertainty from timelines
- Method and cleaning validation suited to lipid‑based and lipophilic softgels
- Experience supporting BCS II–IV and HPAPI softgel programs
- Transparent plans, dedicated team members and regular updates
Commercial‑ready softgel expertise
Douglas CDMO has extensive expertise in the development and manufacturing of softgel capsules, having developed approximately one-third of the pharmaceutical softgels available in the EU and U.S. markets.
Our softgel and lipid‑based programs are supported by predictable timelines, transparent communication, and the technical expertise to manage complex molecules without unnecessary rework. When your molecule needs a high‑performing softgel, our team delivers:
- Commercial‑ready know‑how proven across global launches
- Reliable softgel transfer from development to scale‑up
- US‑focused support for regulatory, CMC, and PPQ activities
- In‑house softgel specialists with decades of experience
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.