Douglas CDMO Auckland New Zealand
Douglas Research and Development facility collaborates with universities, researchers, and clinicians around the globe to find solutions for a range of unmet medical needs.
Some of the life changing human trials managed by the team at the Douglas Innovation facility includes treatments for inflammatory bowel disease, cervical dysplasia, and a very encouraging medicinal candidate helping those with treatment resistant depression. The Douglas development team can translate this research into formulations and manage clinical studies that assess safety and effectiveness in a small number of patients.
The Douglas Development Teams are accomplished in a range of pharmaceutical development activities:
Formulation Team
- Pre-formulation – Characterization of API
- Formulation – Quantitative formula and its process
- Scale-up and Process Validation – Transferring to commercial scale
- Regulatory submission support – P2 and deficiency response
Validation Team
- Validation of developed test methods
- Process validation on registration or commercial batches
- Method transfer between laboratories
- Method verification (in-house and contract laboratory)
- Master validated test methods
Stability And Quality Team
- Manage GMP testing of all registration batches on stability at all stations
- Release testing of raw materials, finished product, and clinical batches
- Support regulatory affairs for dossier Submission Ensure adherence to GMP requirements – data checking of validation, stability data, release testing results for raw materials and finished products
- Drafting CoA for both raw materials and FP for manufacturing or release for clinical trials
- Driving Lab Investigation Process and initiating Quality Investigations
Douglas Technical Services
Our scientists, technicians and analysts who work in the Douglas facility in Auckland are highly qualified, with their expertise supported by Science & Research Internships.
Among our employees at Douglas there is a rich depth of knowledge and intellectual competence in formulation, microbiology, process development, and quality control procedures.