Regulatory Intelligence
At Vigilare Biopharma, our Regulatory Intelligence (RI) solutions enable pharmaceutical and medical technology companies to design efficient strategies for product development, registration, and market entry across diverse jurisdictions. We analyze evolving global regulations to equip sponsors and marketing authorization holders with timely, accurate, and region-specific insights needed for compliance and commercialization success.
Our tailored RI offerings support the entire product lifecycle from pre-market feasibility and strategic planning to post-market monitoring ensuring informed regulatory decisions that minimize risks and accelerate approvals.
Vigilare’s Regulatory Intelligence Support
Drugs Regulatory Intelligence
Vigilare Biopharma’s Drug Regulatory Intelligence (DRI) services are designed to help pharmaceutical and biopharmaceutical organizations navigate complex, country-specific regulatory environments. We understand that precise and up-to-date information can determine the success of product registration and launch.
Our Drug RI specialists deliver:
- Targeted Country Regulatory Overviews
- Focused Regulatory Query Responses
- Pre-registration Regulatory Assessments
- Lifecycle Monitoring
Medical Devices Regulatory Intelligence
Our Medical Devices Regulatory Intelligence (MDRI) services provide critical insights to help manufacturers and distributors comply with varying national and regional device regulations. We support companies throughout the device registration, certification, and post-market phases, ensuring robust compliance management aligned with local authority expectations.
Key offerings include:
- Global Market Entry Insights
- CDSCO & International Compliance Support
- Post-market Surveillance Integration
- Authorized Representative (AR) and Agent Guidance.
Why Choose Vigilare Biopharma
- End-to-End Intelligence Coverage: From pre-submission strategy to post-market compliance tracking.
- Tailored Insights by Product Type: Specific to drugs, biologics, and medical devices.
- Accuracy and Speed: Verified intelligence curated from evolving health authority updates.
- Global Reach: Covering EU, UK, USFDA, CDSCO, ASEAN, and emerging markets.
Facts to Focus
Cases Processed
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North American Submissions
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Signal Reports Delivered
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Aggregate Reports
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Testimonials
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.
Enhance Your Safety Strategy
Navigate the regulatory maze of Life Sciences with Vigilare
Vigilare