Company Category: Scientific & Technical Consulting

Agricultural Technology Research Institute

Agricultural Technology Research Institute

To strengthen the commercialization and industrialization of agricultural research results, the Council of Agriculture (COA) completed the preparatory works and established Agricultural Technology Research Institute (ATRI) on January 1, 2014. Under the ATRI there are Animal Technology Research Center, Plant Technology Research Center, Aquatic Technology Research Center, Business Promotion Center, and Agricultural Policy Research Center respectively in charge of related affairs. ATRI was formed by combining the following agencies: DPIAB – Development Program of Industrialization for Agricultural Biotechnology AgriTI – Office for Agricultural Technology Industry ATIT – Animal Technology Institute Taiwan COAT – Commercialization Office of Agricultural Technology Mission and Task To create a framework for the industrialization of agricultural technology and the development of entrepreneurship, provision of agricultural technology and commercialization/industrialization service to agribusiness, agricultural groups and farmers. 1.To work collaboratively with academia, other research institutes, and private sectors to develop innovative and useful technologies for commercial production. 2.To commercialize and industrialize agriculture research results. To provide assistances to private sectors in strengthening competitiveness and promoting international markets. 3.To serve as an intermediary platform for policy think-tanks. 4.To combine all efforts in promoting the common interests in agricultural area. Facilitations of decision-making process to provide solid foundation for agricultural policies in all forms. | x | To strengthen the commercialization and industrialization of agricultural research outcomes, the Ministry of Agriculture (MOA) completed the preparatory work and established the Agricultural Technology Research Institute (ATRI) on January 1, 2014. Under the ATRI there are Planning and Development Department, Administrative Services Department, Animal & Plant Health and Production Research Center, Agricultural Facilities and Environment Research Center, Agricultural Input and Product Valorization Research Center, Agricultural Policy Research Center and Industrial Development Center respectively in charge of related affairs. ATRI was formed by combining the following agencies: DPIAB – Development Program of Industrialization for Agricultural Biotechnology AgriTI – Office for Agricultural Technology Industry ATIT – Animal Technology Institute Taiwan COAT – Commercialization Office of Agricultural Technology

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Accelsiors-logo-2016

Accelsiors Gmbh

Accelsiors is a global, full-service CRO accelerating clinical development with AI-driven insights, Quality by Design (QbD), and patient-centric solutions. From Phase I to regulatory approvals, we optimize trial execution, ensuring speed, compliance, and success. Visit us at BIO 2025 in the German Pavilion to explore how we can advance your next clinical breakthrough. At Accelsiors CRO, we accelerate biopharmaceutical innovation through a science-driven, patient-centric approach. As a global, full-service CRO, we provide tailored clinical trial solutions designed to de-risk development, optimize timelines, and bring transformative therapies to market faster. With a proven track record in global clinical development, we navigate the complexities of modern drug research—from early-stage clinical development to regulatory approvals and patient-centric trials. Our strategic approach, cutting-edge AI analytics, and deep therapeutic expertise ensure seamless execution and measurable outcomes. | Accelsiors CRO – Science-Driven Clinical Excellence Accelsiors is a global, full-service CRO accelerating clinical development with AI-driven insights, Quality by Design (QbD), and patient-centric solutions. From Phase I to regulatory approvals, we optimize trial execution, ensuring speed, compliance, and success. Visit us at BIO 2026 in the German Pavilion to explore how we can advance your next clinical breakthrough. Let’s discuss how we can accelerate your next clinical breakthrough with Accelerant™, our proprietary Penta-Helix approach—a unique integration of science, patient-centricity, Quality by Design, AI-driven state-of-the-art technologies, and speed with cost-effectiveness at every stage of clinical development.

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00661214

A2 Healthcare

A2 Healthcare(A2), a Japan-Taiwan industry leader for clinical development, spearheads global new drug development in Japan from its new US office in Boston area. A2 is the expert for clinical development in Japan and Taiwan. We are interested to invest in our partner’s pipeline for entering drug development, especially for drugs which are already marketed or under development outside of Japan. Clinical Development: A2 is the leading Japanese CRO providing contracted services in the clinical stage. A2 have the capability and experience to support our partners from early to late phases in any therapeutic area, as well as regulatory consultation and submission. A2 is a subsidiary of ITOCHU Corporation which is one of the largest Japanese company and were awarded the Best CRO of the Citeline Intelligence Award 2023. Pipeline Investment A2’s “Pipeline Accelerator Program (PAP)” supports the development of novel drug candidates enter Japanese market by becoming co-developers with the sponsor. In other words, we will invest in your clinical development cost. Through the program, we will enable domestic and foreign biotech startups as well as pharmaceutical companies for entering the Japanese market with a much lower hurdle. | A2 Healthcare Corporation (A2) is a Japan-based full-service CRO and a core member of the ITOCHU Group, one of the largest Japanese trading and investment conglomerates. With approximately 1,300 employees and offices in Tokyo (HQ), Osaka, Taiwan, and Boston, we focus on helping overseas biotech and pharma companies enter and succeed in the Japanese and Taiwanese markets. A2 has been recognized for excellence in clinical operations and partner satisfaction, receiving the Best CRO/CDMO award (2023) and Best Contract Research Organization award (2025) at the Citeline Pharma Intelligence / Citeline Japan Awards. Key points about A2, the ITOCHU Group and our Japan-entry platform: ◆A2 operates J-STEP (Japan Strategic Entry Platform), a one-stop service platform developed together with ITOCHU to support overseas companies across the full product lifecycle in Japan. ◆J-STEP services include: -Japan market and regulatory assessment, PMDA / ICCC strategy, and early pricing and access considerations. -Japan clinical development planning and execution aligned with global programs. -CMO/CDMO coordination and supply chain support tailored to modality. -NDA support, PMS, real-world evidence (RWE) studies, safety, logistics, and MAH services. -Business development and out-licensing support to Japanese pharma companies using ITOCHU’s local network. ◆In 2026, ITOCHU Corporation acquired 100% of CoreMed Co., Ltd., a leading Japanese regulatory and development-strategy consulting firm. ◆CoreMed provides consulting from early development strategy and CMC evaluation through PMDA consultations and marketing authorization applications, supported by a strong network with EU and US regulatory experts. ◆By combining CoreMed’s regulatory and scientific expertise with A2’s clinical operational capabilities, the ITOCHU Group offers integrated “Strategy + Execution” support for Japan, from first regulatory assessment to approval and post-marketing. ◆Therapeutic area experience spans oncology, rare diseases, regenerative medicine and ATMPs, infectious diseases and vaccines, as well as major and specialty indications. ◆Phase I through Phase III, PMS, and RWE studies, including: -Regulatory and clinical strategy development. -PMDA meeting preparation and briefing packages. -Site selection, site management, monitoring, data management, biostatistics, medical writing, safety, and project management. -ICCC coordination and regulatory submissions. -Post-marketing surveillance and observational research. ◆As part of the ITOCHU Group, A2 can also support: -Partnering and out-licensing between overseas biotech and Japanese pharma. -Flexible collaboration models such as co-development, risk sharing, and selective financial support for Japan-focused assets. -Strategic use of ITOCHU’s global networks, including ITC Venture Partners in Silicon Valley and A2’s Boston office. ◆We are looking to connect with: -Overseas biotech and pharma companies seeking a Japan development and regulatory partner. -Companies interested in one-stop Japan market entry using J-STEP. -Partners exploring co-development, risk sharing, or out-licensing opportunities for the Japanese market. Our goal is Your Goal.

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00952047

A&O Pharma GmbH

Are you looking for a smart and cost saving solution for the import of your products into the EEA, the EU re-analysis and batch release? If your answer to one or more of the questions is “yes”, then A&O Pharma GmbH is your partner of choice. We provide Quality and Compliance, Regulatory Affairs and Analytical Services fast and efficient. Our Quality and Compliance Services: – QP services incl. takeover of QP function, batch release FDF/IMP – Product import FDF/IMP – GxP issue solving incl. Qualification and Validation, Tech Transfer, and comprehensive risk assessments (incl. Elemental Impurities & Nitrosamines) – GxP Quality System and license applications – Inspection Readiness (EU/FDA) – Vendor Management incl. risk based qualification and audits – QA services: management of CAPA, change control, deviations, complaints, self-inspection, preparation of PQR – Interim Management, staff augmentation – Education and Training Our Regulatory Affairs Services: – Submission of MAA and CTA – Scientific Advise Procedures, communication with Health Authorities – Lifecycle maintenance incl. variations and renewals, product information and labelling texts – Information Officer in accordance with §74a AMG – Support for product launches and Merger & Acquisition projects – Preparation of IMPDs, MAA Dossiers Our Analytical Services: – A state of the art, fully digitalised analytical laboratory – Release-testing / EU-Retest of Finished Dosage Forms (FDF) – Analytical method transfer and validation – Trace analysis by LC-MS/MS (e.g. Nitrosamines in APIs and FDF) – Fast, efficient order processing | QP Services and Batch Release A&O Pharma GmbH examines and monitors the GMP-compliant manufacturing of your medicinal products and carries out the QP release in the EU region according to §16 AMWHV by our Qualified Person according to § 14 AMG through: – Monitoring of GMP-compliant manufacturing and testing throughout the entire manufacturing process – QP release of clinical investigational and comparator products for use in clinical studies of phases 1 – 3 (Annex 13 EU GMP guideline). – EU batch releases of registered medicinal products (Annex 16 EU GMP guideline) – Qualification of your suppliers and manufacturers Regulatory Affairs One of our specialties is supporting your drug approval processes and clinical trial applications as well as the subsequent life cycle management. We provide you with advice and support right from the start and reliably guide you through the complex landscape of regulatory requirements. – Advice on regulatory strategy – Interim Marketing Authorisation Holder (iMAH): Application for marketing authorisations and acting as interim marketing authorisation holder after marketing authorisations have been granted in the EU until the authorisations are transferred to a commercial partner of your choice. – Support with scientific advice processes – Submission of marketing authorization applications and clinical trial applications, communication with authorities, compilation of IMPDs and MAA dossiers – Life cycle management incl. submission of variations and extensions – Information officer according to § 74a AMG, preparation and review of product information texts and labelling – Support for product launches and merger & acquisition activities Strategic GxP consulting and operational QA support Position your company and your product on a high quality level and offer patient safety through the advice and support of A&O Pharma GmbH. In doing so, we are at your side with the following services: – Analytical Method Validation – Establishment and optimization of a QM system – Education and Training – Support for inspection by authorities – Conducting audits – Facillity and equipment qualification – Transfer and validation of processes Analytical services Use our chemical/pharmaceutical analytical laboratory at the Itzehoe site as your contract laboratory for GMP-compliant analysis of your finished goods and raw materials. We develop and validate your analytical methods and carry out special tests, such as trace analysis (e.g. nitrosamines in active ingredients and medicinal products, aflatoxins in plant products). Fully digitized processes enable fast and efficient processing of your samples.

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