Features of Pharmaceutical Services

Since the establishment of the Pharmaceuticals Division at SCAS in 1995, we have provided comprehensive testing services for nearly 30 years to a diverse clientele, including pharmaceutical companies, startups, and academia. Our expertise spans the fields of bioanalysis, Chemistry, Manufacturing and Controls (CMC), and regulatory science. Each year, we provide a wide range of pharmaceutical testing services to over 150 companies. We offer extensive support across all phases of drug development, from research and development to data acquisition and document preparation for new drug application, and release testing of approved drugs.

SCAS delivers end-to-end analytical support across all phases of drug development, from non-clinical and clinical studies, through translational research, to post-marketing monitoring and assessment of therapeutic efficacy. We possess advanced technologies, including liquid biopsy such as exosome analysis, for biomarker measurement. These capabilities enable us to perform exploratory and quantitative analyses of novel biomarkers for the treatment of various diseases, including oncology and rare ones.
For the analysis of medium and large-size molecules, such as nucleic acids and antibodies, we are developing cutting-edge methodologies, taking advantage of LC-MS/MS (liquid chromatography-tandem mass spectrometry) and ELISA (enzyme-linked immunosorbent assay), in compliance with ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines and regional regulations. Our innovative approaches significantly enhance the speed and efficiency of global drug development at our clients.

For small molecules, SCAS has supported global regulatory submissions for over 30 years, conducting more than 3,500 stability tests for application purposes. In the area of large molecules, we have been entrusted with testing since around 2005, fulfilling approximately 3,000 requests from over 80 companies. For regenerative medicine for cell and gene therapies, we have implemented advanced testing methodologies since around 2014, accumulating experience with about 950 analyses from 60 companies.
Our release testing services encompass products, including small and medium-size molecules, biologics, regenerative medicine for cell and gene therapies. In all analytical domains, we pride ourselves on our industry-leading technical capabilities.
In terms of analytical technology development, SCAS is dedicated to the characterization and impurity profiling of nucleic acids using 2-dimensuonal LC/MS. We participated in the AMED (Japan Agency for Medical Research and Development) project "Development of Manufacturing, Purification, and Analytical Platform Technologies for Nucleic Acid Drugs" from FY2021 to FY2025, contributing to the advancement of next-generation therapeutic and diagnostic technologies. Our research achievements have been presented annually at the Nucleic Acid Therapeutics Society of Japan and have received high academic acclaim.

SCAS provides regulatory submission support services for pharmaceuticals intended for the Japanese market, including the preparation of quality and stability evaluation documents for submission to Pharmaceuticals and Medical Device Agency (PMDA). We have assisted with over 50 pharmaceutical products of our clients by facilitating their rapid and reliable approval processes through phases from submission preparation to approval acquisition.
For Japanese clients pursuing global business expansion, we offer comprehensive support for overseas Drug Master File (DMF) registrations. Our services encompass data compilation, document preparation and communication with regulatory authorities in each country, by offering meticulous and tailored assistance throughout the DMF registration processes.

SCAS has established an independent department, separated from our analytical laboratories, to implement an effective pharmaceutical quality system (PQS) for our pharmaceutical business. We continuously gather the latest information on Japanese and international regulations, guidelines, and major pharmacopoeias (Japanese Pharmacopoeia, USP, and EP), and rigorously maintain the data integrity (DI). Our quality system is promptly updated to reflect increasingly stringent regulatory requirements.

Since 2008, SCAS laboratories in Oita and Osaka have regularly undergone GMP (Good Manufacturing Practice) inspections by regulatory authorities including the US FDA (Food and Drug Administration), European MHRA (Medicines and Healthcare Products Regulatory Agency), Brazil, South Korea, Russia, and Japan’s PMDA. For GLP (Good Laboratory Practice), we have continuously received GLP compliance certification from PMDA since 1998.
In the past four years (FY2022–2025), we have been audited annually by approximately 30 client companies, consistently earning their high evaluations for our quality assurance system.