Douglas CDMO has all the elements to take your product from idea through to commercialization, and the capability to handle your high potent APIs.
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.
Learn more about 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.