Programs offered by DDIC can help lead to successful approval of pharmaceutical products and NHPs. DDIC’s expertise in dosage form development, analytical testing and regulatory affairs is especially suitable for small to medium sized enterprises (SMEs) and university researchers looking to commercialize their novel drug candidates, combination products or novel dosage forms.
DDIC offers the following advantages of expertise:
- accelerated drug candidate commercialization
- early risk assessment
- development of value added products
Value Added Products
The Centre is unique in Western Canada and provides Alberta companies access to valuable resources needed to commercialize pharmaceuticals. It enables advancement of drug candidates to the prototype development and clinical trials material stage. The Centre also offers dosage form development and production of novel delivery systems.
University based researchers and small to medium sized bio-pharmaceutical companies often face challenges in commercializing products due to unique product requirements and the lack of an interdisciplinary team. DDIC will provide complementary capabilities in the following areas:
- product development
- analytical development
- regulatory support and training
This allows companies to focus on their core functions while enabling advancement of drug candidates to the next stage. The Centre has access to a network of specialists and service providers who can be instrumental in the commercialization continuum.
Early Risk Assesment
If the risks in drug development process are identified at earlier stages and integrated into the drug discovery process it can improve the success rate of drug candidates.
This risk management approach along with the quality formulation development and scale-up readiness can effectively shorten the time to market. DDIC can help in lead optimization and selection and minimize risks of drug failure in the clinical stages. The center can offer to design a project specific compliance platform, designed on the principles of Quality by Design with comprehensive risk management. To implement this approach at an early stage can help researchers and industry to address quality issues more effectively throughout the product life-cycle.