Vigilare

We are Vigilare BioPharma, a global Regulatory partner for Pharmaceuticals, Generics, Consumer Healthcare Products and Medical Devices. Founded in 2014, Vigilare Biopharma is a fast-growing, ISO-certified Clinical Research Organization (CRO) focused on the safety assessment and regulatory compliance of pharmaceuticals. Backed by 10+ years of expertise in Life Sciences and MedTech and with a deep understanding of global health authority procedures, including US FDA, EMA, CDSCO, and more, we support the development of safe, effective, and trusted medicinal products and their global market reach. Our goal is to promote the safe and effective use of pharmaceutical products and to ensure that patients receive the trusted quality of care. What We Do? At Vigilare, our priority lies in simplifying challenging regulatory pathways for pharmaceutical and medical device manufacturers. With cross-functional expertise and robust domain knowledge, we bring to the table end-to-end regulatory solutions that span from preclinical to post-market. We are committed to enabling innovative, and compliant product development through our regulatory intelligence-driven specialized Centers of Excellence (CoEs) in- Pharmacovigilance- Medical Writing, and - Regulatory Consultation Why Us? We are Vigilare BioPharma. We are proven and certified by global regulatory authorities. Our Certifications include: • ISO 9001:2008 Certified • Backed by EU/US GMP certifications through inspections from leading EU inspectorates • Successfully inspected by global health authorities, including MHRA (UK), USFDA (USA), EMA (Europe), SUKL (Czech Republic), MEB (Netherlands), INFARMED (Portugal), and BfArM (Germany) • Maintained a 100% success rate in regulatory inspections over the last 10 years Facts to Focus • 3,700+ Signal Reports delivered • 52+ Audits & Inspections conducted • 2,600+ Aggregate reports delivered • 9+ Regulatory inspections at client location conducted • 206 K Cases Processed