Safety reporting checked before it's submitted.
Individual case safety reports, PSURs, and Risk Management Plans carry direct regulatory exposure. Avidara reviews your pharmacovigilance documentation against SAHPRA's requirements and the ICH E2 series - before it reaches a regulator or a periodic deadline.
Minutes.
Report in your inbox, fast
50+
Regulatory frameworks encoded, platform-wide
100%
Your control preserved
Zero gaps
Consistent every review
Active Reviews
AVD-00042
Review in progress · In Review
AVD-00039
Previous review · Complete
AVD-00031
Queued document · Pending
Compliance Review - AVD-00042
Pharmacovigilance · Safety Reporting · PSUR · Risk Management · Document analysis complete
Findings
Critical non-conformance identified. Requires correction before approval.
Major deviation from regulatory requirement. Action required.
Incomplete supporting documentation. Cross-reference missing.
Minor formatting non-conformance. Advisory.
The challenge
A gap in a safety report is not a formatting issue.
Pharmacovigilance teams work under continuous reporting pressure - individual case safety reports on tight clocks, PSUR narratives that must reconcile against line listings and reference safety information, and Risk Management Plans that need to stay current across every market a product is sold in. A missed signal, an unreconciled case count, or a stale reference data sheet does not surface until a regulator asks about it.
Avidara reviews your ICSRs, PSURs, and RMP documentation against SAHPRA's pharmacovigilance guideline and the ICH E2 series - E2A definitions, E2B reporting format, E2C PSUR structure - so inconsistencies are caught before submission, not after.
Outdated reference safety information
The PSUR's safety assessment is benchmarked against a superseded core data sheet rather than the current Reference Safety Information. Every listedness determination in the report is built on the wrong reference point, which undermines the entire signal evaluation.
Undisclosed safety signal
A signal already under evaluation elsewhere in the safety system does not appear in the PSUR's signal section. Omitting a known signal from the periodic report is a direct pharmacovigilance compliance gap, not a documentation oversight.
Case count mismatch
The cumulative case total stated in the narrative summary does not reconcile with the underlying line listing. Reviewers and regulators rely on this figure to gauge exposure and reporting rate - an unreconciled mismatch undermines the report's credibility.
Incomplete RMP status update
The Risk Management Plan annex has not been updated to reflect the current status of a risk minimisation measure in one market. A small gap on its own, but one that compounds if it recurs across reporting cycles.
What is Avidara
Not a consultancy. A compliance intelligence layer.
Avidara encodes the regulatory rulebook for your industry and applies it consistently, exhaustively, and independently every review. The methodology is universal. Only the ruleset changes per industry.
"The market invested in compliance infrastructure. Avidara addresses compliance intelligence. That is the gap."
The findings are ours. The decisions are yours.
01
Speed beyond human capacity
Every PI reference cross-checked, every claim validated, every mandatory element verified - in parallel, not sequentially.
02
Exhaustive consistency
No reviewer fatigue. No commercial pressure. The same rigour from finding one to finding fifty - every single time.
03
Independence preserved
Avidara flags, analyses, and reports. Your team reviews, validates, and owns every decision. Control stays with you - always.
How it works
Three steps. Zero ambiguity.
You bring the document. Avidara brings the rulebook. You get a clear, structured finding report before anything leaves your desk.
New Review
Drop your document here
PDF, DOCX, XLSX, PPTX, JPG, PNG - max 50 MB
PSUR_Amlorex_ReportingInterval-04.pdf
3.1 MB · ICH E2C(R2) · Review Ready
Why Avidara
Built differently, by design.
No internal bias
Avidara answers only to the regulatory rulebook, not to commercial timelines, marketing budgets, or launch pressure.
Intelligence, not checklists
Findings come with context - the exact PI section, why it matters, and what correction is required. Not a flag, a path forward.
Control stays with your team
Avidara produces findings. Your team reviews, validates, and owns every decision. We are a prerequisite to your compliance decision, never a substitute.
Universal methodology, vertical rulesets
The same analytical framework whether the document is a pharma PI, a transport permit, or a chemical SDS. Only the encoded ruleset changes.
Consistent at scale
No reviewer fatigue, no variation between team members. The same rigour from review one to review one thousand.
Structured for your compliance record
Every report formatted for direct inclusion in your compliance record - with version control, outcome status, and sign-off blocks.
Documents stay in our environment - by design
All AI processing runs within Avidara's private cloud infrastructure. Your documents are never transmitted outside that environment and never used to train any model - by contractual terms and by architecture. The uploaded file itself is automatically and permanently deleted 90 days after upload, never indefinite - your findings and report stay available in your review history for the life of your account.
Systematically monitored, not static.
Avidara monitors regulatory sources relevant to your industry daily, and new sources are added as your account is onboarded. Detected changes are reviewed and incorporated into the applicable checklist - not applied automatically, but never left unaddressed.
Not in Pharmacovigilance?
Avidara serves multiple regulated industries with the same analytical rigour - only the ruleset changes.
Book a review
Ready to close your compliance gaps?
Two ways to engage - pick the one that fits your situation, or tell us what you need and we will recommend the right approach.
No commitment required. We will confirm scope and turnaround before any work begins.