About Us
We Are Vigilare BioPharma
An ISO-Certified Clinical Research Organization
We are Vigilare BioPharma, your 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 drug products.
Backed by 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 medicines and medical products for global markets. Our goal is to promote the safe and effective use of pharmaceutical products and to ensure that patients receive the highest quality of care.
Our Vision
Empowering global healthcare by ensuring compliant, safe, and effective medicines through innovation and a steadfast focus on quality.
Our Mission
To accelerate the introduction of life-saving therapies and drugs to the world market through compliance-driven regulatory services.
Why Us?
We are Vigilare BioPharma. We are proven and certified by global regulatory authorities. Our Certifications include:
ISO 9001:2008 Certified
Demonstrating our commitment to consistent quality and process excellence.
EU/US GMP certification
Backed by EU/US GMP certifications through inspections from leading EU inspectorates.
Inspected by
MHRA (UK), USFDA (USA), EMA (Europe), SUKL (Czech Republic), MEB (Netherlands), INFARMED (Portugal), and BfArM (Germany).
100% success rate
Successful regulatory inspections over the last 10 years—reflecting our unwavering focus on compliance and quality systems.
Work Process
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 in
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