Nucro-Technics offers a broad range of services that cover both modern and classical analytical chemistry techniques to fulfill regulatory testing requirements for the Pharmaceutical, Biologic, Medical Device, and other related industries. Being a contract laboratory, we are not limited to having expertise in a specific product class or for a particular therapeutic indication.
Analytical Chemistry studies conducted at Nucro-Technics are compliant with Good Manufacturing Practices (GMP) regulations as defined by the FDA, Health Canada, and the European Medicines Association. These GMP chemistry studies are used to support the release of finished drug product to the market or to justify the use of a lot of raw material in a product formulation. Where needed, method development, method validation, method transfer, and method verification activities can be conducted to fulfill regulatory requirements.
Nucro-Technics’ chemistry group also supports GLP dose formulation and pharmacokinetic (PK) studies. These dose formulation and PK studies are part of an Investigational New Drug (IND) submission and are used in order to support moving into clinical trials.
MOST COMMON SERVICE OFFERINGS FOR GMP & GLP-COMPLIANT ANALYTICAL CHEMISTRY TESTING
|Service Offering||Service Detail|
|HPLC & UPLC Assays|
|GC (Gas Chromatography) Testing|
|Ion Chromatography Testing|
|Elemental Impurities / Elemental Analysis Testing|
|Other Instrumental Capabilities Commonly Requested|