| CMC&QS offers a full range of analytical
services supporting drug development throughout the entire
development cycle. CMC&QS performs or can assist in method
development and validation, method transfer, stability studies,
specification setting and investigations, always with the
assurance that proper documentation will be provided.
Methods review
Creation and review of analytical procedures to ensure
that methods are appropriate for their intended purpose
Methods development
Technical support in development of novel analytical
methods
Technical support in optimization of existing methods
Methods validation
Validation services customized to client needs ranging
from high-level review of validation protocols, data,
and reports, to full management of the complete validation
process
Preparation of validation protocols and reports
Compliance with the appropriate regulatory guidelines
Technology transfer
Technical support for vendor selection: assisting and
conducting laboratory compliance assessments
Creation of project plans defining project scope and
timelines
Preparation of method transfer protocols
Review of existing data to provide recommendations for
acceptance criteria
Setting specifications
Advice on setting specifications for drug substances,
drug products, starting materials or intermediates
consistent with current regulatory guidelines
Managing stability studies
Design of new studies and creation of stability protocols
in compliance with ICH guidelines
Review of existing stability studies including trending
and statistical analysis
Creation of stability reports
Investigations
OOS investigations support
Laboratory deviations management
Analytical Documentation
Creation and review of the analytical sections and supporting
documentation for the CMC part of submission documents.
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