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.
Cleveland Clinic Innovations
We are more than a tech transfer office. We are a medical innovations powerhouse. Cleveland Clinic Innovations brings the best ideas from the brightest minds in medicine to patients around the world. We connect inventors and their ideas with strategic industry partners to create products that transform the future of healthcare. Cleveland Clinic is changing healthcare for patients around the world. https://39682636.hs-sites.com/bio-home | x | Cleveland Clinic Innovations (CCI) is dedicated to turning caregiver-inspired ideas into medical breakthroughs that meaningfully improve patient lives. Since 2000, our team has transformed over 900 technologies into licensed products, secured more than 2,800 patents, and launched over 100 spin-off companies, achieving 28 successful exits. Our multidisciplinary team works side-by-side with clinicians, researchers, and industry to guide innovations through every stage, from concept to licensing, startup formation, clinical validation, and scaling. We’re more than a technology transfer office, we’re strategic partners in transforming healthcare innovation. Whether it’s harnessing AI for diagnostics, pioneering digital health solutions, developing novel therapeutics, or creating advanced drug delivery systems, we ensure that innovative ideas become practical solutions impacting patient care globally. Technologies available for licensing include: · Digital Health · Drug Delivery · Diagnostics · Therapeutics · Research Tools What Makes Cleveland Clinic Innovations Unique? · Direct clinician and researcher access for rapid, real-world healthcare insights. · Robust clinical validation and real-world data-driven innovation within a globally recognized health system. · Comprehensive IP management, strategic licensing expertise, and proven healthcare startup incubation. Why partner with Cleveland Clinic Innovations? · Expert guidance through healthcare startup creation, technology transfer, and commercialization pathways. · Integrated access to world-class clinical, regulatory, and research infrastructure. · Global presence supporting innovations across markets (U.S., London, Abu Dhabi, Canada). Together, we can accelerate healthcare innovation and create meaningful patient impact. Explore our technologies and partner with us: https://my.clevelandclinic.org/innovations
Cfm Oskar Tropitzsch GmbH
Cfm Oskar Tropitzsch GmbH assists the chemical, pharmaceutical and biotechnological industry in sourcing and producing chemical specialties. The core of our work is to supply the product which our customer is looking for – with the right documentation, the correct quantity from mg to mt and proper quality and this not only for a one shot business but to support projects from RnD state up to commercial production. To achieve these challenging goals Cfm Oskar Tropitzsch GmbH uses its excellent knowhow and worldwide network of qualified suppliers. Finding the best solution! …it’s not just a sentence – it’s our mission! | Cfm Oskar Tropitzsch GmbH assists the chemical, pharmaceutical and biotechnological industry in sourcing and producing chemical specialties. The core of our work is to supply the product which our customer is looking for – with the right documentation, the correct quantity from mg to mt and proper quality and this not only for a one shot business but to support projects from RnD state up to commercial production. To achieve these challenging goals Cfm Oskar Tropitzsch GmbH uses its excellent knowhow and worldwide network of qualified suppliers. Finding the best solution! …it’s not just a sentence – it’s our mission! Our product categories are: -ADC-Payloads -API`s -Contract Manufacturing / Contract Fermentation within Europe/US -Diagnostic Reagents like e.g. DTT -Excipients – Contract Manufacturing of Excipients (g-kg) -Metals & Metal Compounds -Peptide Synthesis -Pytochemicals -Small Molecules (Fermentation Products)
BioMedSA: San Antonio
San Antonio is the 7th largest city in the US and the healthcare and bioscience sector contributes the largest economic contribution in the region. San Antonio is home to the largest military health complex in the US. When combined with the academic and independent research institutions and a collaborative culture, a powerhouse of bioscience capability is formed. The business-friendly climate, low commute times, low cost-of-living, and high quality of life make San Antonio the ideal location for biomedical work. BioMedSA is a non-profit organization dedicated to the growth of the healthcare and bioscience sector in San Antonio and the surrounding region. We accomplish our mission by empowering companies to succeed, promoting the region, and creating actions for growth that benefit the industry and community-at-large. As the hub of the ecosystem, we make vital connections to resources and build collaborations. | BioMedSA is a member-driven hub for the life science industry in San Antonio with the mission to accelerate the growth of the healthcare and bioscience sector, create regional economic benefit, and contribute to the health of San Antonio and beyond. | BioMedSA was founded in 2005 to accelerate growth of the healthcare and bioscience sector, create regional economic benefit, and contribute to the health of San Antonio and beyond by establishing San Antonio as a leader in healthcare and bioscience. BioMedSA serves as the hub for the healthcare and bioscience industry in San Antonio and the surrounding region, connecting people, opportunities and resources, facilitating key collaborations, advocating for industry needs, convening industry leader forums to conquer challenges, and promoting the City of Science and Health. | x
BioHub Taiwan/National Biotechnology Research Park (NBRP)
The major objectives of the BioHub Taiwan (Innovation Incubation Division) are to foster growth among innovative pharmaceutical businesses via networking and joint-venture opportunities, and to provide access to invaluable R&D and marketing resources. This broad mandate is encapsulated in the image of ‘BioHub Taiwan’, which we seek to promote globally. In addition to startups and small businesses, we welcome the installation of mature firms. We adhere to the ideal that vibrant interaction amid a diverse composition will enable the productive exchange of insights and experiences, and we look forward to fruitful outcomes from seedlings that were nurtured in this environment. We also provide space and cooperation schemes for the establishment or extension of internationally leading accelerators, which can maximize the impact of funding from our country’s investors and venture capital funds.
Baylor Scott & White Research Institute
Baylor Scott & White Research Institute (BSWRI), one of the leading research centers for clinical and translational research in the U.S., is the dedicated research and development arm for Baylor Scott & White Health. BSWRI brings together the critical infrastructure and operational resources needed to safely, and effectively, conduct innovative patient-centered research across the largest not-for-profit healthcare system in Texas. Our diverse portfolio of patient-facing research and clinical trials ensures that innovation and education stays at the forefront of our care.
Bakar Labs
Bakar Labs is UC Berkeley’s premier incubator for life science startups developing innovative technologies with market potential. We help companies from pre-seed through Series A focus on the science in cutting-edge fields such as cell and gene therapy. Our community of founders, partners, and investors helps you succeed, reducing barriers to commercialization. We provide lab and office space and facilities sized, priced, and adjustable to your needs. UC affiliation is not required to join Bakar Labs – we take tenants from anywhere. Swing by the California Pavilion to learn more about the resources we provide for early-stage startups! | x
Allsino Pharmaceutical Co., Ltd.
Allsino pharmaceutical Co., Ltd. Your Premier Partner in Small Molecule & Peptide CDMO Services Company Overview Founded in May 2004, Allsino Biopharmaceutical Co., Ltd.is a wholly-owned subsidiary of Sinopep-Allsino Biopharmaceutical Co., Ltd. (Stock Code: 688076), a publicly traded company on the Shanghai Stock Exchange’s STAR Market . Headquartered in Hangzhou, China, Allsino is a globally recognized Contract Development and Manufacturing Organization (CDMO), specializing in the research, development, and production of innovative small molecule drugs, advanced pharmaceutical intermediates, and peptide fragments. With a steadfast commitment to quality and innovation, Allsino serves as a critical bridge between early-stage drug discovery and commercial manufacturing, helping partners accelerate timelines and reduce risks. Strategic Locations: R&D and GMP Manufacturing Allsino operates an integrated Hangzhou R&D + Jiande Manufacturing” dual-site model to ensure seamless technology transfer and scalable production. R&D Center (Hangzhou, Zhejiang): Location: Yuhang District, Hangzhou. Status: Recognized as a Provincial Enterprise Research Institute by the Zhejiang Provincial Government . Capabilities: Houses over 100 scientists, including Ph.D. and Master’s level chemists. The center focuses on core technologies such as small molecule catalysis, continuous flow chemistry, and solid-phase peptide synthesis. – GMP Commercial Production Base (Jiande, Zhejiang): – Location:Jiande City, Hangzhou. – Scale: Spanning 60,000+ square meters(approx. 146 Mu) . – Certification: Operates under strict cGMP standards, compliant with US FDA, EDQM, and NMPA regulations . In 2023, the facility successfully passed the NMPA GMP evaluation for APIs . Core Business & Technical Expertise Allsino is an innovation-driven entity that has successfully initiated and developed over 300 projects across various therapeutic areas, including oncology, central nervous system (CNS) disorders, and metabolic diseases (including GLP-1 analogs for diabetes and obesity) . Key Services: Process Development & Scale-up: From laboratory synthesis to multi-ton commercial production. – Custom Synthesis: Advanced intermediates, Registered Starting Materials (RSMs), and GMP-grade Active Pharmaceutical Ingredients (APIs) . Peptide CDMO Services:Specializing in peptide fragments and oligonucleotides. Commercial Manufacturing: Supporting NDA filings and commercial launch. Quality & Global Recognition Allsino’s commitment to pharmaceutical excellence is validated by its long-standing partnerships with top-tier global pharmaceutical companies. Global Partnerships:The company has established long-term technical collaborations with Fortune 500 pharmaceutical companies such as ****** . Industry Award: In 2022, Allsino was honored with the “SK Pharmteco Preferred Partner Award” at CPhI Frankfurt. Notably, Allsino was the only Chinese company selected among nearly 100 global suppliers to receive this distinction . Intellectual Property: Holds over 20 patents (including inventions and utility models) . Certifications – US FDA (cGMP) – NMPA (China GMP) – ISO 9001, ISO 14001, ISO 45001 Workforce & Assets Employees:500+ , including a highly educated technical team of 240+ professionals (6 Ph.D.s, 16 Master’s degrees) . Annual R&D Investment: Consistently exceeds 10% of revenue, ensuring continuous technological innovation . Contact Information Website:[www.allsino.com](http://www.allsino.com) R&D Center Address: 4F, Building 1, No. 39 Keji Avenue, Yuhang District, Hangzhou, Zhejiang, China (Postal Code: 311121) Manufacturing Base Address:No. 18 Fenghe Road, Xiaya Town, Jiande City, Hangzhou, Zhejiang, China (Postal Code: 311606) Phone: +86-571-89961929 / +86-571-88180350 Email (Sales): sales@allsino.com Allsino pharmaceutical Co., Ltd.—Bridging Innovation from Lab to Market.
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