Douglas is a pharmaceutical contract development and manufacturing organisation (CDMO) providing formulation development, analytical services, clinical trial manufacturing, commercial manufacturing, packaging and supply chain solutions for softgel capsules and liquid dosage forms, including products containing highly potent active pharmaceutical ingredients (HPAPIs).
As a CDMO provider, we hold all major manufacturing certifications for our compliance with Good Manufacturing Practice (cGMP) standards, and currently manufacture and distribute products to over 40 countries. Supported by a world-class team of researchers, scientists, technicians, and project managers, we deliver quality at every stage.
Our process
Once a contract is in place, you can expect your CDMO project to quickly kick off. You’ll be assigned a project team along with a project manager, who will be your primary point of contact.
The process a client will take with us through our various services will differ based on their product requirements and APIs. Whatever your requirements, we will work with you on a solution. Our services cover the entire product lifecycle.
Pre-clinical
Our team can assist in the early stages of your product journey, including:
- Formulation development with Quality by Design principles.
- Solubility screening.
- Solid state screening.
Explore our Formulation development services and Analytical services.
Clinical trial support
Douglas CDMO will help you embark on your clinical trial journey with confidence.
Regulatory support: We can assist in preparing regulatory submissions, including the Investigational Medicinal Product Dossier (IMPD) or Investigational New Drug (IND) applications. In New Zealand, clinical trial applications are reviewed by two main bodies: Medsafe, and HDEC.
Clinical supply services: We can manufacture clinical trial materials for Phase I, Phase II and Phase III, adhering to cGMP. We offer a range of packaging options, including randomized, blinded packing, and global logistics solutions.
Analytical services: We will conduct analytical testing of clinical trial material batches to ensure quality, potency, and stability throughout the clinical trial process.
Commercial manufacturing
We offer comprehensive manufacturing solutions tailored to your product requirements.
Scale up manufacturing: Our manufacturing sites feature high quality equipment and experienced operators. We are committed to high standards of quality and consistency.
Technology transfer: Process validation in accordance with regulatory and cGMP guidelines.
Serialization and batch record documentation: We maintain detailed batch records documenting manufacturing activities, materials used and process parameters.
Learn morePackaging
We offer high-quality packaging solutions to suit your requirements.
Primary and secondary packaging design and development: Our services include filling, sealing and labeling of containers and packs, along with secondary packaging, such as boxes.
Packaging validation: We validate the packaging to ensure the integrity, quality and functionality of packaging materials and configurations.
Learn moreDistribution & logistics
Ongoing lifecycle management: Quality control and assurance, including stability testing, batch release testing and deviation management to maintain product quality and compliance.
Supply chain management: We manage all elements across supply chain including, raw materials, packaging components and finished products.
Learn morePost-launch support
Ongoing lifecycle management: Quality control and assurance, including stability testing, batch release testing and deviation management to maintain product quality and compliance.
Supply chain management: We manage all elements across supply chain including, raw materials, packaging components and finished products.
What pharmaceutical contract development and manufacturing (CDMO) services does Douglas CDMO offer?
Douglas provides end-to-end pharmaceutical contract development and manufacturing services, supporting products from early formulation development through clinical supply, commercial manufacturing, packaging, distribution and ongoing lifecycle management. Our capabilities include pharmaceutical development, analytical services, regulatory support, technology transfer and GMP manufacturing for softgel capsules and liquid dosage forms, with specialist expertise in highly potent pharmaceutical products.
Does Douglas CDMO support both pharmaceutical development and commercial manufacturing?
Yes. Douglas supports the full product lifecycle, from pre-clinical formulation development and analytical testing through clinical trial manufacturing, process scale-up, technology transfer and commercial manufacturing. This enables sponsors to work with a single CDMO partner as their product progresses toward commercialisation.
What dosage forms does Douglas CDMO specialise in?
Douglas specialises in oral dosage forms including softgel capsules and liquid pharmaceuticals. We have extensive experience developing and manufacturing complex formulations, including products containing poorly soluble compounds and highly potent active pharmaceutical ingredients (HPAPIs).
Can Douglas CDMO manufacture clinical trial materials?
Yes. Douglas manufactures GMP clinical trial materials for Phase I, Phase II and Phase III studies. We also provide clinical packaging, analytical testing, stability studies and regulatory support to help sponsors prepare for global clinical trials.
Does Douglas CDMO provide pharmaceutical formulation development?
Yes. Our scientists provide formulation development using Quality by Design (QbD) principles, solubility screening, solid-state screening and formulation optimisation to help create robust, scalable pharmaceutical products suitable for manufacturing and regulatory approval.
Does Douglas CDMO offer analytical testing services?
Yes. Douglas provides analytical method development, validation, stability testing, release testing and routine quality control testing. Our analytical scientists support product development, clinical manufacturing and commercial supply throughout the product lifecycle.
Can Douglas CDMO help transfer an existing pharmaceutical product?
Yes. Douglas supports technology transfer projects for products moving from another manufacturing site or transitioning from development into commercial manufacture. Our teams work closely with clients to ensure process validation, regulatory compliance and reliable manufacturing performance.
Which countries does Douglas CDMO manufacture pharmaceutical products for?
Douglas manufactures pharmaceutical products that are distributed to more than 50 countries worldwide. Our facilities operate to internationally recognised GMP standards and support products intended for global markets.
Why choose Douglas as your pharmaceutical CDMO?
Douglas combines deep scientific expertise with a collaborative, customer-focused approach to pharmaceutical development and manufacturing. From early formulation development through to commercial supply, clients are supported by dedicated project managers and experienced technical teams committed to quality, responsiveness and transparent communication. With decades of experience manufacturing softgel capsules, liquid pharmaceuticals and highly potent medicines to international GMP standards, Douglas helps pharmaceutical companies confidently progress products from development to market.