| CMC&QS offers a full range of services
for support of API development and manufacturing. From evaluation
to validation and beyond, CMC&QS expertise spans the
entire development cycle including, nut not limited to process
evaluation and development, scale-up and troubleshooting,
process validation design and management. These activities
are performed with a focus on clear, concise documentation
of all activities.
Initial process assessment
CMC&QS evaluates existing synthetic methods and provide
assessments of applicability to GMP production. Starting
at any phase, including discovery research, we can determine
where process improvements can be made, balancing both
production and quality concerns as well as the costs
aspect starting from the earliest possible point.
Process development
Continued improvement to chemical processes and product
quality is provided through chemical process development
support. Synthetic pathway design, reagent selection,
purification and isolation methods, all provided with
a strong awareness of the constantly evolving quality
requirements, including the PAT guidance and application
of statistical design and optimization methods. Finally
all processes are designed for a future costs saving
optimization.
Scale-up and troubleshooting
Support of technology transfer between various sites
and equipment types is available. Solutions to issues
likely to occur on scale-up and troubleshooting of
problems that do occur in support of correction action/preventative
action (CAPA) investigations.
Process validation design and management
Process validation is supported throughout the entire
development cycle by using statistically designed experiments
capable of both optimizing critical parameters and
defining acceptable operating ranges. Such information
directly supports generation of process validation
protocols for use in management of process validation
activities.
Active Pharmaceutical Ingredient Documentation
Review and writing of Protocols, Reports for the CMC
part of submission documents.
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