About

About 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.