The Critical Path: Our Vision Working Together for the Future
In order to stimulate and facilitate a national effort to modernize the scientific process for drug design and medical product development, and to help guide the healthcare industry into the 21st century, the FDA has embarked on the Critical Path Initiative.
As Blue Stream Laboratories strategically positions itself for the future, we seek to work with our clients to align programs and to create solutions in the context of the Critical Path Initiative. We provide modern and technically sound laboratory methods and solutions to improve safety, efficacy, quality, and industrial scale-up; all with a keen insight into regulatory requirements and impacts.
Supporting our Clients
We provide:
- Skills and insight to enhance product development programs
- Resources to act as an extension of our clients\' laboratory
Moving the product through the Critical Path
We measure the physio-chemical and biological characteristics of therapeutics to guide product development towards successful clinical outcomes:
- Characterization/Standardization
- Formulation
- Testing
We overcome roadblocks from laboratory concept to production to manufacturing scale-up:
- Process development
- Validation
- Quality control
- Structural "similarity" or equivalence, composition and confirmation, especially taking into account the impact of process changes
We align our programs to enable clients to be at the cutting edge in innovative product development, particularly in the following areas:
- Development of Biomarker Assays
- Proteomics Screening
- Providing the methods for proving therapeutic equivalence
- Formulation
- Potency
