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DouglasNEW ZEALAND.COM Licence No.101032
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  1. About us
  2. Our Operations
  1. About us

Our Operations

Douglas specialises in producing prescription drugs for pharmaceutical classifications including oncology, dermatology, the central nervous system and immunity.

Manufacturing

Manufacturing excellence since 1967

Douglas has manufactured prescription medicines for the New Zealand and international markets for more than 50 years.

All our products are made to international standards known as GMP (Good Manufacturing Practice).

Our manufacturing facilities undergo regular inspections by both local and international authorities, including Medsafe and the US FDA. These inspections confirm the company’s ongoing compliance and provide independent assurance that systems, facilities, and processes consistently meet the high standards expected of modern pharmaceutical manufacturing.

Acitretin

Pharmaceutical capabilities

Our pharmaceutical capabilities include the making of solid oral dose formulations (tablets and capsules) and a variety of liquid, oral and topical formulations (soft gel capsules, solutions, suspensions, creams, lotions and gels).

Douglas Innovation Lab Scientist

Our technical services

Our scientists, technicians and analysts who work in our manufacturing facilities in Auckland are highly-qualified, with their expertise supported by science and research internships.

Among our manufacturing employees is a rich depth of knowledge and intellectual competence in formulation, microbiology, process development and quality control procedures.

Douglas viles

Quality assurance

Quality is a core principle at Douglas and a defining element of how the company operates. Every employee plays an active role in maintaining and improving quality, ensuring that the organisation remains a trusted and reliable partner in the development and supply of medicines.

Douglas applies a continuous improvement mindset across all activities, proactively reviewing systems, processes, and performance. By engaging closely with clients and technical partners throughout the product lifecycle - from development and design through to commercial manufacture and distribution - we deliver consistent value and robust quality outcomes.

Manufacturing softgels

Commitment to quality maturity

Douglas' comprehensive Quality Management System (QMS) is structured to meet the requirements of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products and relevant sections of the US FDA Code of Federal Regulations, including 21 CFR Part 11 for electronic records and signatures.

A detailed Quality Manual outlines the company’s approach to Quality Risk Management (QRM) and Data Integrity, with ALCOA+ principles embedded across processes to ensure data are attributable, legible, contemporaneous, original, accurate, and complete.

Behind these systems is a leadership team that prioritises robust quality oversight and invests in the capabilities needed to uphold it. Through strong governance, rigorous testing, and a commitment to ongoing improvement, Douglas ensures that every product released to the market meets the standards required by regulators and the expectations of patients and partners worldwide.

Regulatory affairs

Our regulatory expertise

Navigating the global regulatory landscape requires a highly skilled and experienced team. We maintain a dedicated regulatory staff committed to ensuring our products are developed and manufactured in full compliance with applicable laws and standards. This expertise is essential for enabling a smooth path to market across diverse international jurisdictions.

Our Regulatory team works closely with Douglas R&D to guide product development, providing strategic insights into the studies and data required to support registration in multiple markets.

Prescription

Registration and post-approval

Registration dossiers are prepared in accordance with internationally recognised guidelines using the Common Technical Document (e-CTD) format - a global standard that streamlines submissions to regulatory authorities worldwide. We partner with clients to ensure applications are submitted, approved, and launch-ready in their target markets.

Post-approval, our Regulatory team continues to support any changes needed to optimise products or processes. We also provide comprehensive data packages to help clients maintain compliance and keep their products in the marketplace.

DML Warehouse
DML production
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