Development
Escientia offers expertise in analytical in-house testing, and services in both FTE and FFS mode.
Our scientists work to create operating conditions and manage programs which are reproducible, cost-effective and environmentally-friendly.
Provides analytical methods such as:
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DOEs to define critical process parameters
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In-house testing, release of raw materials, and packing materials
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Kilo-lab for scalability and robustness demos
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Long-term supply-chain strategies
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Dedicated areas for wet analysis and instrumentation (HPLC, GPLC, and GC)
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Instrument compliance with 21 CFR Part 11 regulations
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Analytical instrumentation powered by Waters Empower 3 networking system
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Stability testing per ICH guidelines (accelerated, long-term, intermediate and zone IVB)
Provides services in both FTE and FFS mode:
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Process research and development of scalable route
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Analytical methods development and validations
Technology transfer -
Impurity identification, isolation and characterization
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PGI review and study
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Particle size-reduction studies
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Process engineering and safety studies