Unlock Our Regulatory IQ
We are Vigilare, your global Regulatory partner for Pharmaceuticals, Generics, Consumer Healthcare Products and Medical Devices.
Backed by years of expertise in life sciences and a deep understanding of global health authority procedures, including US FDA, EMA, CDSCO, and more, we solve critical challenges faced by pharma and medical device manufacturers, i.e., hassle-free, compliant, and timely market-entry of life-saving products.
Industries We Serve
Tailored global regulatory consulting for industries like Bio-pharma, Generics, Biosimilars, Medical Devices, and Consumer Healthcare.
Centers of Excellence
Specialized CoEs for Pharmacovigilance, Medical Writing, and Regulatory Consultation strategically integrated with actionable Regulatory Intelligence.
Global Reach
Trusted for region-specific Regulatory knowledge across 100+ countries, with strong procedural insights into global health authorities like the US FDA, EMA, TGA, MHRA, CDSCO, etc.
Facts to Focus
Audits & Inspections
conducted
conducted
0
Signal Reports Delivered
10
+
Cases Processed
0
K
Aggregate Reports
100
K
Regulatory inspections at client location conducted
0
+
MICC Calls Handled
0
K +
Our Global Expertise
Industries We Serve
Tailored global regulatory consulting for industries like Bio-pharma, Generics, Biosimilars, Medical Devices, and Consumer Healthcare.
Centers of Excellence
Specialized CoEs for Pharmacovigilance, Medical Writing, and Regulatory Consultation strategically integrated with actionable Regulatory Intelligence.
Global Reach
Trusted for region-specific regulatory knowledge across 100+ countries, with strong insights into authorities like US FDA, EMA, TGA, MHRA, and CDSCO.
Enhance Your Safety Strategy
Navigate the regulatory maze of Life Sciences with Vigilare
Vigilare
Explore More Services From Vigilare
Pharmaceutical Regulatory Consulting Services
Strategic regulatory advice, submission support, and compliance solutions tailored for the pharmaceutical industry. Know More💊
Pharmacovigilance Regulatory Support
End-to-end pharmacovigilance services, including adverse event reporting, risk management, and safety monitoring. Know More📑
Regulatory Medical Writing Services
High-quality medical writing services for regulatory documents, including clinical trial reports, protocols, and submission documents. Know More⚙️
MOH Interaction and Regulatory Liaison Support
Expert consulting for regulatory approvals, market access strategies, and compliance with global pharmaceutical regulations. Know More🌍
Pharmaceutical Regulatory Intelligence
Comprehensive market intelligence and insights to navigate the pharmaceutical regulatory landscape globally. Know More🤝
Regulatory Publishing Services for Medical Devices
End-to-end regulatory support for drug development, from preclinical to post-market phases, including submission preparation and strategy. Know More🏥
Medical Device Labeling Services and Technical Writing Support
Regulatory compliance, pharmacovigilance reporting, and safety surveillance to ensure product safety in the global market. Know More🛡️
Regulatory Compliance Consulting, Gap Analysis and Remediation
Expert regulatory writing for safety reports, risk assessments, and other compliance documentation tailored for the pharmaceutical sector. Know More📊
Medical Device Submissions and Medical Device Registrations
In-depth analysis of regulatory trends, market access strategies, and policy changes to keep your pharmaceutical business ahead. Know MoreTestimonials
Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.
We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.
Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.
We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.
Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.
