Regulatory Medical Writing Services
Years of research and drug development lead to a crucial phase – regulatory submissions. But what if your submission documents are riddled with inconsistencies, lack clarity, and consist of misinterpreted, unstructured, and non-compliant data? The consequences might be severe ranging from clarification requests, additional inspections, and outright rejections followed by delays in patient access to vital therapies. This showcases the need for expert Regulatory medical writing services. It isn’t optional, but critical.
At Vigilare, our medical writing experts comprising of PhDs, PharmDs, and domain-experienced, combine scientific accuracy with regulatory intelligence to transform complex research data sets into clear and compliant documentation that meets international guidelines (ICH, EMA, and US FDA).​
Vigilare’s Regulatory Medical Writing Services
End-to-End Clinical Regulatory Writing
At Vigilare, we translate science into strategy. We communicate complex, high-quality, and confidential research data in a clear and audit-ready way. We deal with every scientific document at any phase of Regulatory submission that span across Clinical Protocols, Investigator Brochures, Informed Consent Forms, Clinical Study Reports (CSRs), Safety Narratives, Regulatory Submission Modules, and Patient Education Materials, etc.
PDE/OEL Reports
Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) reports are crucial for cleaning validation, pharmaceutical risk assessments, and to prevent cross-contamination. Establishing and documenting these exposure limits are mandatory for all APIs manufactured especially in multi-product facilities. At Vigilare, our toxicology safety specialists and medical writers generate precise PDE/OEL assessments and document the reports for scientific accuracy and as per the global health authority standards.
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