With
the most modern GLP facilities Ansys provides a full range of
analytical services that includes method development and validation,
analytical testing release, stability study, and regulatory CMC
documentation services. State-of-the-art instruments, leading-edge
technologies, and experienced scientific staff ensures efficient,
superior and cost-effective services with fast turnaround time.
Ansys
provides you comprehensive services with stability protocol design,
program management, storage and testing, data trending/shelf life
assessment up to dossier preparation for regulatory application at
storage conditions according to pharmacopoeia monographs or customized
specifications as per client requirements.
Our
team will support your pharmaceutical innovation program with methods
for stability-indicating assay for related substances/ pharmaceutical
impurity, methods for drug substance/API and drug products (tablets,
capsules/liquid filled capsules, solution/suspension, powder,
beads/coated beads, injectable, topical, solid dispersion formulations). We also will
assist you with other specific methods, like dissolution (IR, ER, MR),
residual solvents/ other volatile impurities, potential genotoxic
impurity, leachable/extractable testing, cleaning validation, etc. Provide method
development protocol, progress report, method validation protocol,
report and/or standard testing procedures with full or customized
release for API and drug product. AnSys
experienced analytical development scientists can accelerate your
development program by working hand in hand with our synthetic chemists
thereby minimizing the overall time taken by your discovery and
development program. Upon completion of the development, AnSys can
qualify or validate the analytical test methods to your rigorous
standards, including challenging the linearity, accuracy and precision
of the methods, ensuring that the method performs over the desired
range.