| CMC&QS provides full FP process support from
development to commercialization with experience in formulation,
technology transfer, validation, manufacturing, commercialization
and documentation.
Formulation
Formulation Development
Scale-up
Technology Transfer
Full support for site to site or internal technology transfer.
Full support in Vendor selection: assisting and conducting
technical and quality review of new Vendor(s) to guarantee
the conformity of the Vendor for clinical phase, validation/stability
batches and commercial batches.
Validation
Full support in Validation activities starting from the determination
of acceptable validation criteria with the available data
(previous studies or manufactured batches), followed by the
documentation like Site Master Plan, Validation Master Plan,
Process and Cleaning Validation Protocols and Reports and
with the preparation of final documentation supporting the
registration.
Manufacturing
Manufacturing is supported throughout the entire production
phases by a continuous evaluation and optimization of the
production cycle to improve the final product specifications,
the quality and costs.
Finished Product Documentation
Review and writing of Protocols, Reports for the CMC part of
submission documents.
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