Your compliance layer. Independent, intelligent, precise.
Avidara stands outside every pharma business it serves — an independent external review layer that finds what internal teams miss, before SAHPRA does.
Minutes.
Report in your inbox, fast
50+
Regulatory frameworks encoded
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
Pharmaceuticals · Life Sciences · 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
Compliance gaps are invisible, until they are not.
Regulatory teams are stretched. Internal reviewers face commercial pressure. Rulebooks never stop growing. One overlooked finding — a wrong dosing figure, a non-PI claim — can delay a launch, trigger a recall, or draw SAHPRA action.
You know your products better than anyone. What you need is a second set of eyes that answers to no one but the rulebook.
Wrong dosing on artwork
Initiation shown as 5 mg BD. PI requires 10 mg BD. Missed across three internal reviews.
Off-label indication creep
Promotional claim extends beyond the approved indication. Not caught before the print run.
Non-PI comparative claim
Superiority language used without supporting data in the approved label.
Address discrepancy
Promotional material address differs from the SAHPRA certificate holder address.
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.
Services
From first submission to ongoing compliance.
Market entry, registration maintenance, labelling, portfolio management, pharmacovigilance — wherever your regulatory workload sits, Avidara has a service for it.
Artwork and Promotional Material Review
Every promotional piece reviewed against the SAHPRA-approved Professional Information. Findings graded Critical, Major, or Minor with exact PI references, locations, and corrective recommendations. Structured for MLR submission.
What you receive
Market Entry
Dossier Bridging
Bringing a product into South Africa or taking a registered SA product into African markets? Module-by-module gap analysis against the destination authority's requirements — before you file.
Dossier Gap Analysis
Module-by-module assessment of your registration dossier against SAHPRA eCTD requirements. Readiness scoring, critical path, and priority action plan before you submit.
Documentation & Labelling
PI, PIL & SmPC Review & Advisory
Expert review and advisory on Professional Information, Patient Leaflets, and SmPCs against SAHPRA requirements — gaps identified, corrective guidance provided, submission-ready. English UK, SI units, scheduling box, bilingual PIL.
Document Version Comparison
Track exactly what changed between two versions of any regulatory document — package inserts, labels, PIL amendments, policies. Upload Version A and Version B. Avidara produces a paragraph-by-paragraph change map showing what was added, removed, or modified. Every material change identified and documented — ready for your MLR file or amendment audit trail.
Post-Registration Variation Review
Changing a label claim, formulation, strength, or manufacturer? Identify the correct SAHPRA variation type, the supporting data requirements, and any conditions you'll need to satisfy — before you file.
This service is scoped per engagement. Contact hello@avidara.co.za or book a call to discuss your specific requirement.
Review Services
MLR & Scientific Publications Review
Medical-Legal-Regulatory review of promotional materials and scientific publications — manuscripts, congress abstracts, and CME content — against current approved data and MLR requirements.
Section 21 Authorisation Review
Seeking SAHPRA authorisation for an unregistered medicine? Review your application for patient need justification, prescriber documentation, safety data completeness, and supporting submission requirements.
This service is scoped per engagement. Contact hello@avidara.co.za or book a call to discuss your specific requirement.
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
Cardivex_HCP_LeaveBehind_A5_v2.pdf
2.8 MB · Reference PI: EVD-NX-001/SA · 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 MLR file
Every report formatted for direct inclusion in your Medical, Legal and Regulatory record — with version control, outcome status, and sign-off blocks.
Zero Data Retention — by design
All AI processing runs within Avidara's private cloud infrastructure. Your documents are never transmitted outside that environment, never stored after processing, and never used to train any model — by contractual terms and by architecture.
Always current.
Avidara monitors regulatory updates from SAHPRA, EMA, FDA, MHRA, TGA, Health Canada, PMDA, NAFDAC, and others — so the review framework reflects current requirements, not last year's guidelines.
Not in Pharmaceuticals?
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.