Douglas has expertise in the formulation of innovative drug delivery options for the enhancement of bioavailability of poorly soluble compounds.
Our processes ultimately lead to a robust quality product with clear development specifications. You can be confident in the dosage, accuracy, stability, and safety of a Douglas CDMO product.
After 56 years, we know how to optimise and deliver a dosage form which meets the requirements of global health authorities. Established quality by design (QbD) methodologies ensure the development of a robust and reproducible manufacturing process that is cost-effective and consistently produces a finished dosage with the gold standard in performance and quality every time.
Douglas CDMO understands the key steps of formulation design, pre-formulation studies, process engineering, scale-up, and the necessity for stability data to support a safe and efficacious medicine for the patient.
Dose Form Design
In the dose form design process, extensive testing and quality control measures are implemented to ensure safety, efficacy, and consistency of the final product according to the principles of Quality by Design.
This includes evaluating factors such as dissolution characteristics, physical integrity, and uniformity of fill.
Our understanding of developing analytical methods for bioavailability enhancement, modified release and SoftGel technologies bring your ideas to the clinical stage – fast.
We ensure the accuracy, reliability, and consistency of analytical methods used to assess the quality, safety, and performance of pharmaceutical products.
Douglas has comprehensive capabilities for developing methods for the identification, quantification, and characterisation of active pharmaceutical ingredients (API’s), impurities, degradation products, and other critical components. The objective is to develop methods that provide reliable and reproducible results with adequate sensitivity and specificity to meet the unique needs of the product under analysis.
We integrate seamlessly with our Quality Control team to ensure methods are transferred effortlessly and ready to meet commercial demands.