ABRACRO, Brazilian Association of CROs, is a non-profit association that brings together and represents CROs established in Brazil, to contribute to the improvement of the regulatory processes of clinical research in the country and stimulate the development of scientific and educational activities linked to the sector. Founded in 2005, ABRACRO represents foreign and Brazilian CROs operating in the whole country, and brings together other service providers that work with a focus on clinical research, such as logistics and customs companies. The association also aims to ensure the practice of ethics and obedience to the rights of volunteers involved in clinical trials, following the Brazilian and international regulatory standards. It is also the ABRACRO’s mission to support the education and training of clinical research professionals | ABRACRO is a non-profit association that brings together and represents CROs established in Brazil and other companies that act in clinical research, to contribute to the improvement of the regulatory processes of clinical research in the country and stimulate the development of scientific and educational activities linked to the sector. Founded in 2006, ABRACRO represents 35 foreign and Brazilian companies operating in the whole country. The association also aims to ensure the practice of ethics and obedience to the rights of volunteers involved in clinical trials, following the Brazilian and international regulatory standards.
AAPharmaSyn, LLC
AAPharmaSyn, LLC (Ann Abor based and US owned) is a global research organization that provides Superior Drug Discovery Chemistry Solutions. We specialize in: 1. Medicinal Chemistry (hit to lead, lead optimization and scale up, SAR, etc. mg to 1 kg); 2. Process Research and Development (route scouting, route optimization, scale up, etc. up to 5 kg); 3. Custom and Exotic Research Tool (unique ADCs, lipids, flavonoids, carbohydrates, intermediates, etc.). AAPharmaSyn is built on the premise that application of the fundamental principles of synthetic organic chemistry toward salient problems leads to superior results. Our investment in how we solve problems and execute synthetic strategy saves money and time. | AAPharmaSyn, LLC is a US-based and owned global contract research organization (CRO) specializing in medicinal chemistry, drug discovery, process development, and non-GMP manufacturing. Headquartered in Ann Arbor, Michigan, the company was founded in 2006 by former Pfizer scientists and is staffed by senior chemists with deep expertise in organic synthesis, medicinal chemistry, and chemical process optimization. Since its inception, AAPharmaSyn has demonstrated consistent growth by delivering high-quality, reliable, and innovative solutions to a diverse client base—including government agencies, pharmaceutical and biotechnology companies of all sizes, and academic research institutions. The company’s core strengths include rigorous execution, scientific creativity, proactive problem-solving, and transparent communication. To further expand its capabilities and market reach, AAPharmaSyn actively pursues strategic collaborations with industrial partners and academic institutions, supporting the development of new products, acquisition of enabling platform technologies, and entry into emerging markets. Company Brief: 1. History: Founded in 2006 (ex-Pfizer). Based in Ann Arbor, MI (all work performed locally). BBB A+ rating. >800 projects successfully completed. 2. Team: Each team member has 10+ years of synthetic organic chemistry experience. All Ph.D.’s with multiple publications and patents. Academic pedigree: Yale, Princeton, Harvard, UC Berkeley, Purdue, UM. 3. Key Attributes: communication and problem-solving 4. Reputation: Our client testimonials speak to the value we deliver. (https://aapharmasyn.com/customer-testimonials/) Key services: • Medicinal Chemistry: high-throughput screening outcome triage, lead development, scaffold-hopping, structure-based design, structure activity relationship (SAR) development • Custom Organic and Peptide Synthesis: including ADC’s, complex carbohydrates, lipids, API impurities, intermediates, metabolites, etc. • Route Scouting and de novo Process Development: non-GMP scale-up (up to 5 kg batch size)
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.
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.
3D Pharma Consulting Ltd
Established in 2019, 3D Pharma Consulting Ltd is based in Cardiff, UK and provides CMC (chemistry, manufacturing and control) support to small and medium sized pharmaceutical companies. With expertise in the technical, operational and quality elements required for the development of new drugs and technologies, 3D Pharma Consulting works closely with customers’ in-house teams to design, execute and manage drug development programmes that deliver the required technical outputs and business goals. 3D Pharma Consulting provides expert knowledge of drug delivery, including long-acting/controlled release formulations, targeting technologies and transdermal. Complex parenterals and non-standard manufacturing processes are an area of particular expertise. 3D Pharma Consulting Ltd has a broad network of contract manufacturers and will support the selection, set-up and management of drug product supply chain for cost-effective and compliant clinical manufacture. | Established by Dr Paul Seaman in 2019, 3D Pharma Consulting Ltd is based in Cardiff and provides CMC (chemistry, manufacturing and control) support to small and medium sized pharmaceutical companies. With expertise in the technical, operational and quality elements required for the development of new drugs and technologies, 3D Pharma Consulting works closely with customers’ in-house teams to design, execute and manage drug and device development programmes that deliver the required technical outputs and business goals. Complex parenterals and non-standard manufacturing processes are an area of particular expertise. 3D Pharma Consulting Ltd has a broad network of contract manufacturers and will support the selection, set-up and management of drug product supply chain for cost-effective and compliant clinical manufacture. Product/Service: 3D Pharma Consulting Ltd provides CMC development services to companies as they prepare for clinical trials, including: – Development of drug delivery solutions and formulations – Manufacturing process development, scale-up & technology transfer – Regulatory guidance and document preparation – R&D and manufacturing project management