Our expertise also covers the transfer of technology. This is the process of transferring information, documentation, methods, processes, and skills related to the drug development formulation, analytical testing, and manufacturing from one location or organisation to another for the successful development, manufacturing, and commercialisation of a drug product.
At Douglas, control of our processes and prevention of cross contamination is our highest priority. We manage our analytical cleaning method development and process cleaning development simultaneously.
These services are critical for maintaining a controlled and sterile environment necessary to produce pharmaceutical products. Douglas follows Good Manufacturing Practice (GMP) and guidelines from organisations like the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These help ensure the integrity and safety of pharmaceutical products by minimising the risk of contamination and maintaining a controlled manufacturing environment.
Process Validation and Scale-Up
Douglas is here to support you in all elements of the scale up and process validation procedure. We have long experience in performing lifecycle management activities in all areas of our manufacturing capabilities.
We understand how to scale-up, tech-transfer and validate processes rapidly and with focus on product quality.
From consideration of the equipment at the new site, to understanding critical process parameters, to handover of manufacturing and quality control methods, we can support your product in ensuring the validation is as smooth and seamless as possible.
At our Douglas facility in Auckland, we create tablets, SoftGel capsules, hard shell capsules, liquids and creams, and packaging solutions in an EU, FDA and TGA cGMP manufacturing facility.
As well as prescription drugs for various therapy areas including oncology, dermatology, the central nervous system, and immunology.
Based in Auckland, New Zealand, Douglas has a reputation for high manufacturing standards, quality products and outstanding customer service. Douglas has proven expertise in successful integration of development, clinical supply, and scale-up technology transfers.