Aggregate reports
VigiDirect
In VigiDirect, we have extensive experience in pharmacovigilance writing, ensuring that reports we create for you are precisely crafted, regulatory-compliant, and submission-ready.
Writing high-quality pharmacovigilance documentation such as:
- Pharmacovigilance System Master File (PSMF),
- Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs),
- reports on Serious Unexpected Suspected Adverse Reactions (SUSARs),
- Development Safety Update Reports (DSURs),
- Individual Case Safety Reports (ICSRs),
- Signal Assessment Reports, Addendum to the Clinical Overview (ACO)
- or SmPc/PIL translation
Writing high-quality medical device vigilance documentation such as:
- Post-Market Surveillance (PMS) Plans and Reports (per MDR Article 83)
- Periodic Safety Update Reports (PSURs) for Medical Devices (per MDR Article 86)
- Trend Reports (per MDR Article 88)
- Serious Incident Reports (in line with MDR vigilance obligations)
- Field Safety Corrective Action (FSCA) Reports
- Post-Market Clinical Follow-up (PMCF) Plans and Reports
- Medical Device Incident Investigation Reports
- Vigilance Documentation for ISO 13485 Compliance
These documents have to be clear, structured, and fully aligned with regulatory requirements to ensure a smooth submission process to competent authorities such as EMA, national authorities or EUDAMED. Errors, inconsistencies, or missing information can lead to delays, additional queries, or even regulatory non-compliance. Expertise in this area is essential to ensuring that your pharmacovigilance and vigilance documentation meets the highest regulatory standards, facilitating efficient approvals, compliance, and patient safety.
Document Review and Advisory Services
Some companies prefer to prepare regulatory reports internally but may still need expert guidance to validate compliance with pharmacovigilance and medical device vigilance requirements. That’s why VigiDirect offers comprehensive review and advisory services, ensuring that all safety documentation meets the latest regulatory standards. If you have already drafted a pharmacovigilance or medical device vigilance report, we provide detailed reviews, expert feedback, and necessary revisions to enhance its accuracy, completeness, and compliance.
Our goal is to streamline your regulatory submissions, minimizing potential objections or delays. Ensuring that all pharmacovigilance and vigilance documentation meets the highest industry and regulatory standards. With our expertise, your reports will be precisely structured, regulator-ready, and fully compliant, safeguarding both regulatory approval processes and patient safety.