As a recognized leading scientific and regulatory consulting firm within the pharmaceuticals and biotechnology industries, our team of scientific and regulatory consultants will help you identify the most efficient drug development and registration pathways. As a science-based consulting firm with clients from all over the world, Intrinsik’s full-time, in-house, scientific and regulatory consultants will support the development of a wide range of human health products, including small molecules, biologics, cell and gene therapies, natural health products (NHPs), and cosmetics from the preclinical stage through to market and the post-approval phase. Intrinsik’s Services: Regulatory Affairs Consulting Nonclinical Consulting Medical Writing Chemistry, Manufacturing and Controls (CMC) Regulatory Operations Toxicological Services
Hanmi Fine Chemical
Hanmi Fine Chemical was established in 1984 and has since grown into a world-class, Active Pharmaceutical Ingredient company through ceaseless technological developments and facility investments based on a foundation of talented people with creativity and challenge-seeking spirits. We are a pharmaceutical company that exports Active Pharmaceutical Ingredients to more than 40 countries through strategic alliances with global companies and by establishing independent technologies and a world-class quality system with excellence. HanmiCap, our proprietary 5′ cap analog for mRNA IVT is a state-of-the-art cap analog series that provides excellent translation efficacies and COGs for the overall success in your mRNA drug. | USFDA approved GMP manufacturer in South Korea. Peptide CDMO PEG CDMO Polymer/Lipid CDMO Small Molecule CDMO mRNA materials – HanmiCap, Pseudo UTP, M1-Pseudo UTP, etc
H&T Presspart
H&T Presspart is a world leader and specialist in manufacturing drug delivery devices and pharmaceutical components. With 50 years experience in partnering with the world’s leading pharma companies we have developed a strong reputation for precision and reliability – critically important when patients’ quality of life depends on our products. Our extensive skills and experience cover drug delivery device development and industrialisation and every aspect of high-volume precision deep-drawn manufacturing, injection moulding and high-speed assembly in ISO 7 and ISO 8 cleanrooms.
eXmoor Pharma
eXmoor is a full service Cell & Gene Therapy CDMO with a difference. We are backed by 20 years CMC consultancy experience, supporting over 150 organisations to accelerate novel therapies from discovery to patients. We provide expert solutions at all stages of the development journey from early process development and scale-up through to GMP manufacture, fill and finish and QP release. We are open, transparent and will work with you at every step to de-risk and streamline your project and maximise the chances of product success. | eXmoor Pharma is a full-service Cell & Gene Therapy CDMO with a difference. Backed by over 20 years of consultancy experience, we’ve helped more than 170 organisations accelerate therapies from discovery to delivery. We deliver more than manufacturing. Our integrated consultancy and technical development services span the full journey from early-phase strategy to GMP manufacturing and commercialisation. Our in-house experts work as an extension of your team, helping you plan, scale, and deliver therapies that are clinically and commercially viable. We bring deep domain knowledge across process development, analytical science, facility design, GMP production, and regulatory strategy. With a purpose-built facility and a commitment to full IP freedom, we give innovators the space and flexibility to focus on what matters most: getting life-changing treatments to patients faster.
ExcellGene
ExcellGene is a leading biotechnology company specializing in developing and producing high-quality recombinant proteins and monoclonal antibodies, with expertise in CHO and HEK-293 cell lines. With over 20 years of experience in the field, our dedicated team of experts ensures reliable, timely, and efficient customized solutions meeting the highest quality standards for a wide range of research, diagnostic, and therapeutic applications. Visit our booth #1743 to learn more about our services and products, and go to www.excellgene.com for additional information or to get in touch. | ExcellGene is a leading biotechnology company specializing in developing and producing high-quality recombinant proteins and monoclonal antibodies, with expertise in CHO and HEK-293 cell lines. With over 20 years of experience in the field, our dedicated team of experts ensures reliable, timely, and efficient customized solutions meeting the highest quality standards for a wide range of research, diagnostic, and therapeutic applications. | Looking for a trusted partner in the development of cell lines and manufacturing processes? Look no further. With over 20 years of experience, we specialize in high-yielding (5-14 g/L), GMP-ready, CHO, and HEK293 cell lines for the production of biologics, biosimilars, and gene therapy (AAV, Adenovirus). We have a proven track record of expressing all types of proteins, including bi-specific mAb, Fc-fusions, viral proteins, cytokines, and more. Our team of scientists is ready to support your project from start to finish, including process development, analytical methods, scale-up, tox-batches, and Master Cell Banking. At our company, we pride ourselves on our commitment to quality and customer satisfaction. Contact us today to see how we can help you achieve your goals and be your trusted partner in cell line and process development.
EirGenix, Inc.
EirGenix is the leading company in biologics development and GMP manufacturing and has solid experience in various biologics (mAb, bi-specific mAbs, r-proteins, COVID-19 Spike protein, fusion proteins, RNA, ADC, Viral Vector, etc.). As of now, we have successfully completed more than 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA has been submitted to the US FDA in December 2021. Among others, our services include: – Up to 12×2,000L SUB mammalian cGMP production capacity – Dual cell Line development & banking for mammalian and microbial systems – Upstream/Downstream process development – Analytical and QC – One-stop full service from DS to DP – US FDA inspected and the EIR report received – Japan PMDA and Taiwan FDA certified – Biosimilars pipeline available for licensing and or collaboration | EirGenix is a leading CDMO in biologics development and GMP manufacturing that has solid experience in various biologics (mAb, BsAbs, r-proteins, COVID-19 Spike protein, fusion proteins, ADC, pDNA, Viral Vector, etc.). We have completed > 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA was approved in the EU and waiting for US FDA approval. Among others, our services include: – One-stop full service from DS to DP CGMP Clinical and Commercial manufacturing of Microbial and Mammalian strains – Up to 12 x 2,000L mammalian capacity – Dual Cell Line Development & banking for mammalian and microbial systems – Upstream/Downstream process development – Analytical and QC – US FDA, Japan PMDA, Australia TGA, EU EMA, and Taiwan FDA inspected – Biosimilars pipeline available for licensing and or collaboration | EirGenix is Taiwan’s leading biologics CDMO, providing end-to-end development and manufacturing solutions that meet FDA, PMDA, EMA, and TGA standards. Since 2012, we have successfully delivered 100+ projects across mammalian and microbial platforms, supporting global clients from early-stage development to commercialization. Our comprehensive services include cell line development, process and analytical development, and cGMP manufacturing for both clinical and commercial supply. With a robust 12 × 2,000L single-use bioreactor capacity and expanding microbial fermentation capabilities, we are equipped to handle large-scale production needs. Award-Winning Excellence Since 2017, EirGenix has been consistently recognized for excellence in biologics development and manufacturing, earning multiple prestigious industry awards that demonstrate our commitment to innovation and quality. Recent Awards (2023-2025): – Best ADC CDMO in Taiwan – Asia Pacific Biopharma Excellence Awards 2025 – Most Promising Monoclonal Antibodies Pipeline – Taiwan Biopharma Excellence Awards (TBEA) 2024 – National Science and Technology Drug R&D Award – Gold Medal (2023, Taiwan) (for EirGasun® 150mg) – BioProcessing Excellence Award – Greater China Region (2022) (IMAPAC Asia Biologics – Manufacturing Conference) Accelerate your biologics development with EirGenix. Visit us at BIO 2025 or contact us to explore tailored solutions for your next project.
Ecolab Life Sciences
Ecolab’s Purolite™ Resins receive continued investment from Ecolab to support development, production, and customer support. We have one of the industry’s largest technically trained sales teams in ion exchange and specialty resin technology, backed by five Research and Development centers, nine application labs and five production facilities. With our ability to quickly respond, supply, and develop, we can solve your application challenges and optimize your system. Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry. Our comprehensive solutions and technical expertise are focused on cleaning, sanitization and contamination control, all while ensuring safety, compliance and operational efficiency. Our strategy is to stay focused on two core areas: Global Trends and Regulatory Changes that impact your operations, and develop solutions to keep you on the cutting edge. | Ecolab Life Sciences is a segment of Ecolab and a global leader in technologies and services designed to enhance productivity, reduce costs, and accelerate the development of critical medicines. Leveraging over a century of innovation, Ecolab Life Sciences provides comprehensive solutions and expert guidance across bio-decontamination, drug purification, active pharmaceutical ingredients (APIs) and excipients. With a strong commitment to ensuring safety, compliance, and operational efficiency, Ecolab Life Sciences partners with organizations to support their mission of advancing health and wellbeing worldwide.
Cytovance Biologics
Cytovance Biologics, Inc. (Cytovance Biologics) is a leading biopharmaceutical contract development and manufacturing organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs). Cytovance Biologics utilizes both mammalian cell culture and microbial fermentation to express monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines, and other biological products, including plasmid DNA and cell-based therapeutics. In addition to its clinical and commercial CGMP API manufacturing services, Cytovance Biologics offers well-integrated development services supporting the entire product lifecycle, including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. Our state-of-the-art facilities in Oklahoma City are designed to meet United States, European Union, and other global regulatory standards. Cytovance Biologics offers deep industry expertise and unique customized services for the scale-up and CGMP manufacture of protein-based therapeutics; from early-stage pre-clinical development to commercial production, for both mammalian and microbial. Further information can be found at www.cytovance.com. | Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) offering ingenuity and integrated development services to support large molecule biologics throughout the journey from R&D to regulatory approval. These services include mammalian cell line development, cell banking, microbial strain development, process and analytical development, process characterization, and cGMP manufacturing. The company’s 140,000+ sq. ft. state-of-the-art facilities in America’s Heartland are designed to meet US, EU, and global regulatory requirements. Find out more at https://cytovance.com/ | Streamline your biomanufacturing with a US-based partner that is large enough to support you at every stage but small enough to stay agile and provide your program with the care it deserves. Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) offering ingenuity and integrated development services to support large molecule biologics throughout the journey from R&D to regulatory approval and commercial supply. These services include mammalian cell line development, cell banking, microbial strain development, process and analytical development, process characterization, and cGMP manufacturing. The company’s 140,000+ sq. ft. state-of-the-art facilities in America’s Heartland are designed to meet US, EU, and global regulatory requirements.
Cytiva
With a rich heritage dating back hundreds of years, Cytiva brings a wealth of technical expertise and talent, a broad and deep portfolio, and exceptional service help researchers and biopharma advance therapeutics at every stage from discovery to delivery. We supply the tools and support our customers need to work better, faster, and safer, leading to the delivery of transformative medicines to patients. Our combined portfolio includes well-recognized names such as Allegro™, Supor™, iCELLis™, and Kleenpak™, in addition to ÄKTA™, Amersham™, Biacore™, FlexFactory™, HyClone™, MabSelect™, Sefia™, Whatman™, and Xcellerex™. Visit cytiva.com to learn more. | Diagnostic assays like the ones you’re developing are in demand. Set yourself up for success by choosing a supplier that delivers quality products for your entire workflow and offers specialized services and capabilities needed to commercialize your assays. Using a single supplier for multiple components, from membranes to magnetic beads, can streamline your development process and ultimately accelerate the commercialization of diagnostic assays and kits. Cytiva can help you speed up and scale up without staffing up! With a rich heritage dating back hundreds of years, Cytiva brings a wealth of technical knowledge and talent, a broad and deep portfolio, and exceptional service to support biotechs at every stage from discovery to delivery. Visit cytiva.com/diagnostics to learn more. | Cytiva and Pall Life Sciences have come together to deliver the breadth, depth, and scale researchers and biopharma need to advance future therapeutics – from discovery to delivery. Together, as Cytiva, we supply the tools and support our customers need to work better, faster and safer, leading to the delivery of transformative medicines to patients. Our combined portfolio includes well-recognized names such as Allegro™, Supor™, iCELLis™, and Kleenpak™, in addition to ÄKTA™, Amersham™, Biacore™, FlexFactory™, HyClone™, MabSelect™, Sefia™, Whatman™, and Xcellerex™. | Cytiva is a global life sciences leader that works with academic and translational researchers, developers and manufacturers of biotherapeutics, cell and gene therapies, and new technologies such as mRNA, to enable the delivery of transformative medicines. Cytiva is a trusted expert with nearly 10 000 associates in 43 countries dedicated to customers’ speed, flexibility, capacity and efficiency in drug discovery, research, and manufacturing.
CRQA
CRQA: Your Trusted GxP Compliance and Regulatory Consulting Partner Company: CRQA (Compliance, Regulatory & Quality Assurance) Headquarters: Noida, Uttar Pradesh, India (Office No. 602, 6th Floor, Tower B, B8 Noida One, Sector 62) Website: www.crqa.in Contact: bd@crqa.in | +91 98100 68241 Tagline: GxP Compliance: We have got you covered Who We Are CRQA is an independent, specialized auditing and regulatory consulting organization headquartered in New Delhi/Noida, India. Unlike large contract research organizations (CROs) that offer quality assurance as an add-on, CRQA was built exclusively around GxP compliance — making regulatory excellence our sole focus, not a side offering. Registered with Dun & Bradstreet, ISO 13485 & ISO 9011:2015 certified, and recognized as an MSME, CRQA has positioned itself as a credible and conflict-free compliance partner for pharmaceutical companies, biotechnology firms, clinical research organizations, medical device manufacturers, and healthcare institutions worldwide. Global Reach CRQA operates across more than 60 countries and delivers its services in 30 languages, making it one of the most geographically diverse independent GxP auditing firms in the world. Our network of Auditors spans: • Asia: India, Japan, China, Southeast Asia, including major Indian cities — New Delhi NCR, Noida, Gurgaon, Mumbai, Pune, Bangalore, Chennai, Hyderabad, Kolkata, Ahmedabad, Vadodara • Americas: United States, Latin America • Europe: EU countries, UK • Middle East & Africa • Australia & Oceania This wide geographical presence enables us to deploy region-based auditors who understand local regulatory environments — reducing travel costs and turnaround time for our clients. Why CRQA? — The Value Proposition CRQA was founded to address a critical gap in the pharmaceutical services industry: the absence of a dedicated, independent auditing agency free from conflicts of interest. Key advantages of working with CRQA: ✔ No conflict of interest — CRQA is purely an auditing and consulting firm; we do not run clinical trials or offer CRO services, ensuring full objectivity in every audit. ✔ Specialized expertise — Our auditors are seasoned professionals with deep GxP knowledge, offering a level of focus that generalist CROs cannot match. ✔ Cost efficiency — With locally based auditors across 60+ countries, clients benefit from significant cost savings on travel and logistics. ✔ Better sponsor–CRO relationships — By outsourcing audits to CRQA rather than using competitor CROs, sponsors can maintain neutral, healthy vendor relationships. ✔ Holistic compliance perspective — Our external auditors provide an unbiased, big-picture view of a client’s systems, identifying gaps and improvement opportunities that internal teams may overlook. Services Portfolio CRQA provides a comprehensive suite of GxP auditing and regulatory consulting services: Clinical & Research Compliance • GCP (Good Clinical Practice) Audits and Services • GCP Consultancy • Mock Inspections • BA/BE (Bioavailability/Bioequivalence) CRO Audits • Remote GCP and Pharmacovigilance Audits • Vendor Audits • Study Audits Manufacturing & Distribution Quality • GMP (Good Manufacturing Practice) Audits and Services • GDP (Good Distribution Practice) Compliance • GLP/GCLP (Good Laboratory/Clinical Laboratory Practice) Audits • Pharmaceutical Quality Management Services Pharmacovigilance & Drug Safety • Pharmacovigilance Audits • QPPV (Qualified Person for Pharmacovigilance) Services • Global Pharmacovigilance Outsourcing Services Medical Devices • Medical Device Regulatory Audits and Consulting • ISO 13485 Quality Management System Support Regulatory Affairs & Strategy • Regulatory Pathway Consulting Services • Global Pharmaceutical Outsourcing Services • Dossier Submission Support (Feasibility to Filing) • Qualified Person (QP) Services in Europe Technology & Systems Compliance • Computer System Validation (CSV) • Compliance Training on 21 CFR Part 11 Quality Systems & SOPs • Quality Management and Compliance Systems • SOPs Development and Review Training & Education • Online Training and Workshops • Ethics Committee / IRB Training • Compliance Training Programs Key Clients CRQA has earned the trust of a diverse global clientele, including recognized names across pharma, biotech, medical devices, and healthcare and have worked with wide range of pharma, biopharma and medical device clients from USA, Europe, India. Certifications & Recognition • D-U-N-S Registered (Dun & Bradstreet Verified) • ISO 13485 Certified (Medical Devices Quality Management Systems) • ISO 9001 : 2015 • MSME Recognized (Government of India) Our Differentiator at BIO USA At a conference where partnerships are forged and life sciences innovation meets business strategy, CRQA stands out as the go-to independent partner for: • Pharma and biotech companies entering new markets who need local regulatory audit support • CROs and sponsors seeking objective, third-party GxP compliance evaluations • Medical device companies needing ISO 13485 audits and regulatory consulting • Global life sciences firms looking for cost-effective, scalable compliance solutions across multiple geographies Whether you are preparing for an FDA, EMA, or CDSCO inspection, building your quality management infrastructure, or seeking ongoing pharmacovigilance oversight — CRQA delivers expert, independent, and conflict-free compliance support. Connect With Us at BIO USA kshahani@crqa.in +91 98100 68241 www.crqa.in LinkedIn: CRQA India CRQA — GxP Compliance: We Have Got You Covered.