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