At Douglas, we are committed to being a premier contract development and manufacturing company (CDMO) partner for our pharma clients and patients alike.
Quality management and assurance are at the core of our business. We strive for unparalleled leadership, compliance, and service in every stage of the drug development project life cycle.
At Douglas, we believe that quality is the responsibility of every employee. The high standard of our products and services is a competitive advantage upholding Douglas’ reputation as a trusted and reliable CDMO partner to innovative drug product organisations.
Through innovation, our quality operating procedure seeks to add value to every step of the design, development, production, and distribution process. Douglas is well versed in risk-based decision-making processes made successful by our tried and tested scientific judgement and positive work environment.
With a focus on continuous improvement, we proactively review our systems and engage with our pharmaceutical industry customers to ensure we always deliver the highest value to their businesses.
Our Quality First Mindset
Our promise to customers is simple: we are dedicated to upholding the current industry standards and committed to offering quality pharmaceutical products, processes, and services to achieve customer and patient satisfaction. The necessary environment, training, and tools are available to support this commitment.
We will maintain a quality system designed to comply with cGMP requirements as defined by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and foreign regulatory agencies.
Douglas Manufacturing is inspected by the local regulatory authority Medsafe as well as the TGA and US FDA.Learn more
The Regulatory Pathway
Thanks to secured agreements and accreditations with our international market partners, we have the ability to export to the EU without the need to retest for quality.
These approvals include The Ministry of Health Mutual Recognition Agreement, Therapeutic Goods Administration (TGA), Good Manufacturing Practice (GMP), and the Food and Drug Administration (FDA) certifications.
The manufacturing processes and technologies used at Douglas are regularly audited by New Zealand and international Health Authorities. This multinational compliance system ensures the quality and integrity of our products from concept to commercial, before they are shipped to our customers.