Insuvia is a trusted partner for biotech companies seeking regulatory compliance and pharmacovigilance support across clinical development and post-marketing stages. We specialize in helping biotechs navigate complex regulatory landscapes and manage drug safety, whether advancing through clinical trials, preparing for product launches, or expanding globally. | Insuvia is a trusted partner for biotech companies seeking regulatory compliance and pharmacovigilance support across clinical development and post-marketing stages. We specialize in helping biotechs navigate complex regulatory landscapes and manage drug safety, whether advancing through clinical trials, preparing for product launches, or expanding globally. Our tailored operating model is designed to meet the unique needs of biotech companies – offering agility, scalability, and personalized service. As a mid-sized provider, Insuvia combines the capacity to handle complex projects with the focused attention biotechs deserve. Backed by a highly experienced team, we enable our clients to achieve regulatory success and ensure patient safety.
Illinois Economic Development Corporation
Illinois Economic Development Corporation’s mission is to bring jobs, investment, and economic prosperity to the state of Illinois through dynamic partnerships and collaborations with companies, universities, not-for-profit organizations, and the government to deliver a unified approach to economic development. Formerly known as Intersect Illinois.
Harvest Integrated Research Organization (HiRO)
HiRO is a modern global CRO delivering full-service clinical trial support across ANZ (for over 25 years), APAC, US, and Europe. We combine global infrastructure with genuine local expertise, offering sponsors the agility and personalization that larger organizations can’t match, without sacrificing rigor or reach. From regulatory strategy, clinical operation support and management, site identification and management, biometrics, pharmacovigilance and medical monitoring, HiRO accelerates the path from discovery to patients. Highlights ⦁ Modern local CRO operating across ANZ, APAC, US, and Europe ⦁ Full-service: clinical design, regulatory, biometrics, safety, and monitoring ⦁ Global expertise paired with hands-on regional insight ⦁ Agile operations built for faster, cleaner clinical data ⦁ True partnership model, embedded in your team from day one | Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
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.
Granzer Regulatory Consulting & Services GmbH
Granzer Regulatory Consulting & Services offers support in all phases of drug and device development. From defining the right development strategy to submitting a marketing authorisation application, all the way through to approval and beyond, as a one-stop-shop for our clients. We take great pride in supporting our clients with pioneering, innovative, and ambitious strategies. Our track record speaks for itself, as we have been first in the development of peptide-based vaccines, mRNA technologies, CAR-T therapies, CRISPR/Cas advancements, and the first marketing authorisation of a COVID-19 vaccine. We cover all types of therapies and diagnostics (small molecules, biologics, cell and gene therapies, drug-devices and many more) in all indications. This includes paediatric as well as orphan development, PRIME and Accelerated Approval pathways. Delivering on this promise for more than 20 years, we have supported more than one thousand clients in Europe, North America, Japan, Australia, and Asia.
GlobalData
GlobalData has decades of experience in being the trusted, gold standard intelligence provider to leading Pharmaceutical brands, manufacturers, and suppliers, helping them to make faster, more informed decisions. | GlobalData is a data and analytics company providing the Life Science Community with Market and Competitive Intelligence. GlobalData serves over 4,000 world’s largest companies with over 600 healthcare analysts by gaining insights into competitors, evaluating market opportunities, and provide strategic opinions in the Pharma/Biotech, CMO/CDMO, CRO, Medical Device/Medtech and Consumer Health industries. From research and development, clinical trials, business developments to investment due diligence, our clients can make better business decisions on our fully integrated one-stop intelligence center platform. | GlobalData’s Construction portfolio offers insights across the entire global construction market, from market-sizing, companies, construction innovations, risks, regulatory developments, M&A, and financial transactions, to projects and project contacts. Our connected Construction Intelligence offers the most comprehensive coverage of construction projects available, tracking new construction projects totaling over US$70tn globally from announcement to completion, by sector, stage, scope, and more. Our industry leading portfolio of brands include Cranes Today, Tunnels & Tunnelling, and World Construction Network amongst others, and have informed the construction landscape since 1969.
FGK Clinical Research GmbH
FGK provides full service for clinical studies to biotechnology, medical device and pharmaceutical companies. FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor. With our more than 200 highly qualified medical, scientific and regulatory experts, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report. Full service or partial services for conduct of clinical trials including: * clinical trial management and clinical monitoring * regulatory submissions * biostatistics * data management * eSolutions * medical writing * medical safety * quality assurance * pharmacovigilance * consulting services FGK also offers legal representation services for sponsor companies conducting trials in the EU without having a subsidiary there. | FGK is a European, owner-managed Clinical Research Organization providing full service for clinical studies to biotechnology, medical device and pharmaceutical companies. FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor. With our 240 highly qualified medical, scientific and regulatory experts in the EU and the UK, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report. Full service or partial services for conduct of clinical trials including: ▷ clinical trial management and clinical monitoring ▷ regulatory submissions ▷ biostatistics ▷ data management ▷ eSolutions ▷ medical writing ▷ medical safety ▷ quality assurance ▷ pharmacovigilance ▷ consulting services; — FGK also offers legal representation services for sponsor companies conducting trials in the EU without having a subsidiary there (www.fgk-rs.com) and post-market pharmacovigilance services (www.fgk-pv.com).— | FGK Clinical Research GmbH is a full service Contract Research Organization with offices in Germany (HQ), Poland, Czech Republic, Hungary, UK and US. We provide full service for Phase I – IV clinical studies. Our international client base includes biotechnology, medical device, and pharmaceutical companies. FGK has the right size to handle multi-country, multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor. With our about 240+ highly qualified medical, scientific and regulatory experts, we have all the knowledge and experience necessary to succeed and can guide you through the clinical trial process, from planning and approval to the final report. | FGK is a CRO, offering full service for conduct of clinical trials in all phases, specialized on biotech and medical device companies. Founded in 2002, owner-managed structure, guaranteeing a personal and flexible approach to our clients. FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients but is still small enough to guarantee a personal service to the sponsor. With our 240 highly qualified medical, scientific and regulatory experts, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report. Full service or partial services for conduct of clinical trials including: * clinical trial management and clinical monitoring * regulatory submissions * biostatistics * data management * eSolutions * medical writing * medical safety * quality assurance * pharmacovigilance * consulting services
EPS Group
From our beginnings in 1991 as a systems company built on medical statistics, the EPS Group has responded to customer needs amid structural changes in the market and increasingly rigorous and complex drug development. EPS has evolved as a CRO (Contract Research Organization) and expanded our offerings to include SMO (Site Management Organization) and CSO (Contract Sales Organization) services, thereby becoming a comprehensive provider of various support services for the healthcare industry. CRO： In response to requests from pharmaceutical, medical device and regenerative medicine companies, medical institutions, governmental agencies, and others, the EPS CRO Group provides One-Stop Solutions to support the development of pharmaceuticals, medical devices, foods, and cosmetics. SMO： The EPS SMO Group enhances clinical trials by collaboration with medical institutions across Japan, leveraging digital technology to improve efficiency, including the promotion of Decentralized Clinical Trials (DCTs) and the development of remote systems for clinical trial document management. CSO： The EPS CSO provides targeted support to pharmaceutical and medical device manufacturers after product approval. We provide contact center operations, and a range of services from pre-approval to post-marketing stages, employing a skilled workforce to effectively fulfill customer needs. | EPS Holdings, Inc., a Japanese headquartered company, is a comprehensive provider of clinical trial and research outsourced services. EPS Group, with over 7,800 staff, provides quality support to pharmaceutical, biotech, regenerative medicine, and medical device companies. Core businesses are CRO, SMO, Contract Sales Support, and China product development and distribution. EPS operates in Japan, China, South Korea, and Taiwan and, through a partner, supports studies in other Asia-Pacific countries. Looking towards the future, we will strengthen our forward-looking spirit expressed as an “Ever Progressing System.” | The EPS Group was founded in 1991 as a pioneer in the domestic Contract Research Organization (CRO) industry. Since then, we have expanded our diverse services, including Site Management Organization (SMO) and Contract Sales Organization (CSO), with a primary focus on CRO. We provide end-to-end support solutions from the development of pharmaceuticals, medical devices, and regenerative medicine products to post-marketing surveillance. Building on the foundation of our clinical trial and post-marketing businesses, which boast a top-tier scale and proven track record in Japan, we are actively engaging in data business and new ventures, constantly striving for evolution.
EFOR Group
Founded in 2013, Efor Group is a leading international player in quality and compliance for the Life Sciences industry. With over 3,000 employees across 18 countries, Efor supports leading pharmaceutical, biotech, and medtech companies in securing their manufacturing operations through its expertise in CQV, quality management, and regulatory compliance, while accelerating the delivery of innovative therapies to market. Our mission: to remove technical and regulatory barriers, enabling faster access to innovation while ensuring the highest standards of safety and reliability. Committed to its founding values, Efor fully integrates social and environmental responsibility into its business model and drives sustainable growth built on excellence, commitment, and teamwork. Through its international expansion, the Group aims to establish itself as a global reference in Life Sciences consulting, placing people, health, and safety at the heart of everything it does.
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.