Analytical method development and establishment of specifications

When developing pharmaceutical products, including raw material, intermediates, API and drug products, it is paramount to develop stringent analytical methods and to provide justifications around specifications. SPH can provide support in compliance with latest regulatory directives from the early developing to post approved stage.

• ・Analytical Methods Development (Raw material, intermediates, API and Drug Products etc.)
• ・Analytical Methods Validation required for New Drug Application
• ・Proposal of specifications for the investigational medicinal products and New Drug Application

It is very important but difficult to establish appropriate impurity control strategy in pharmaceutical manufacturing. Shionogi Pharma can propose appropriate impurity control strategy according to the requirements of international regulations (ICH) and can also provide services such as identification of impurity structure and high-sensitivity analysis of trace impurities.

Various unique manufacturing technologies have been developed with technology innovation in recent years. Shionogi Pharma is researching and developing newer evaluation technologies based on our knowledge of physical property evaluation techniques cultivated through long years of experience.

• ・Nano Pharmaceuticals
• ・Solid Dispersion Formulation
• ・Development of process evaluation methods by PAT
• ・Physical property evaluation (particle diameter, crystal form, dissolution speed etc.)

Shionogi Pharma owns high-spec instruments such as EPMA (Electron Probe Micro Analyzer) and SEM (Scanning Electron Microscope) and has dedicated specialists engaged in the analysis and evaluation work. We are able to analyze foreign material on micro-scale that is difficult to detect using conventional methods.

• ・Analysis of coating thickness
• ・Mapping analysis to evaluate uniformity of component
• ・Foreign material investigation, such as form observation and analyses on micro-scale

Huge amount of data and documents according to each regulation are required in a New Drug Application. Please use our experience in regulatory affairs cultivated through global market development. We can also provide draft English application documents.

• ・Preparation of IND (Investigational New Drug) / IMPD (Investigational Medicinal Product Dossier) / CTD(Common technical Document) module 3
• ・Preparation of DMF (Drug Master File)
• ・Improvement of specification and test methods for commercial product, and preparation of application documents for post-approval change.
• ・Investigation requests from the market (stability testing for unpackaged product, compatibility testing, complaint response etc.)
• ・Support work to prepare draft for Japanese Pharmacopeia
• ・Responding to various regulatory matters necessary for pharmaceutical manufacturing (Industrial Safety and Health, Chemical Substances Control Law, Cartagena Act)