regintel. | Tesserblu

/ Qualitus · QMS

Regulatory Intelligence

No regulatory update, no deadline, no label change slips through.

Salvus Regulatory Intelligence monitors global regulatory authorities continuously — EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic and more — and translates updates into product-specific impact assessments, PSUR/PBRER obligation tracking and submission deadline management.

Key capabilities

Global Authority Monitoring

Label Change Alerts

PSUR / PBRER Obligation Tracking

Referral & Signal Tracking

Safety Communication Monitoring

Configurable Watchlists

11+

Authorities monitored

< 4h

Alert to team notification

PSUR / PBRER / DSUR

Obligations tracked

Real-time

Deadline calendar

What it does

All the capability, none of the complexity.

Salvus Regulatory Intelligence monitors global regulatory authorities continuously — EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic and more — and translates updates into product-specific impact assessments, PSUR/PBRER obligation tracking and submission deadline management.

01 Global Authority Monitoring

Continuous monitoring of EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic, GCC, ANVISA and more. New guidances, safety communications and label changes captured within hours.

02 Label Change Alerts

SmPC, PIL and US PI changes flagged against your product portfolio. AI-assisted impact summary indicates changed sections and PV relevance.

03 PSUR / PBRER Obligation Tracking

Aggregate report obligations loaded per product and MA. Submission deadline calendar with 90/60/30/14-day advance alerts. Status tracking through submission and approval.

04 Safety Communication Monitoring

DHPC, Dear HCP Letters, FDA Safety Communications and HA-initiated label change requests tracked and routed to responsible teams.

05 Referral & Signal Tracking

EMA referral proceedings, PRAC signal recommendations and FDA Postmarket Safety Reviews monitored with structured impact assessment per product.

06 Configurable Watchlists

Product-specific watchlists by ATC code, INN, trade name, MA number or therapeutic area. Team-specific routing ensures right people see right alerts.

07 Smart Briefing Generation

AI-generated briefing notes summarise regulatory activity in a period — source, nature of change, product impact and proposed action.

08 Audit & Evidence Repository

Full record of all alerts, impact assessments and responses — supporting inspection-readiness and process maturity evidence.

How it works

From day one to every day after.

A typical journey through Regulatory Intelligence — from onboarding to steady-state operations.

1

2

3

4 Monitor

Continuous automated monitoring of authority websites, document repositories and official journals. AI classifies documents by type and PV relevance.

Alert

Product-matched alerts dispatched to configured teams within 4 hours. Smart briefings summarise what changed and why it matters.

Assess

Product team conducts structured impact assessment: labelling impact, aggregate report obligations, signal implications, correspondence needed.

Act

Actions assigned with owners and deadlines. Progress tracked in the audit record. PSUR obligations auto-updated when new requirements are confirmed.

See It in Action

Watch Qualitus in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

1. Upload the Regulatory Intelligence demo to YouTube.

2. Copy the video ID from the URL — the part after watch?v=

3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"

4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.

5. Save & deploy — the play button handles the rest automatically.

Integrations

Connects where you need it to.

Regulatory Intelligence is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

/ Qualitus · QMS

Regulatory Intelligence

No regulatory update, no deadline, no label change slips through.

Salvus Regulatory Intelligence monitors global regulatory authorities continuously — EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic and more — and translates updates into product-specific impact assessments, PSUR/PBRER obligation tracking and submission deadline management.

Key capabilities

Global Authority Monitoring

Label Change Alerts

PSUR / PBRER Obligation Tracking

Referral & Signal Tracking

Safety Communication Monitoring

Configurable Watchlists

11+

Authorities monitored

< 4h

Alert to team notification

PSUR / PBRER / DSUR

Obligations tracked

Real-time

Deadline calendar

What it does

All the capability, none of the complexity.

Salvus Regulatory Intelligence monitors global regulatory authorities continuously — EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic and more — and translates updates into product-specific impact assessments, PSUR/PBRER obligation tracking and submission deadline management.

01

Global Authority Monitoring

Continuous monitoring of EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic, GCC, ANVISA and more. New guidances, safety communications and label changes captured within hours.

02

Label Change Alerts

SmPC, PIL and US PI changes flagged against your product portfolio. AI-assisted impact summary indicates changed sections and PV relevance.

03

PSUR / PBRER Obligation Tracking

Aggregate report obligations loaded per product and MA. Submission deadline calendar with 90/60/30/14-day advance alerts. Status tracking through submission and approval.

04

Safety Communication Monitoring

DHPC, Dear HCP Letters, FDA Safety Communications and HA-initiated label change requests tracked and routed to responsible teams.

05

Referral & Signal Tracking

EMA referral proceedings, PRAC signal recommendations and FDA Postmarket Safety Reviews monitored with structured impact assessment per product.

06

Configurable Watchlists

Product-specific watchlists by ATC code, INN, trade name, MA number or therapeutic area. Team-specific routing ensures right people see right alerts.

07

Smart Briefing Generation

AI-generated briefing notes summarise regulatory activity in a period — source, nature of change, product impact and proposed action.

08

Audit & Evidence Repository

Full record of all alerts, impact assessments and responses — supporting inspection-readiness and process maturity evidence.

How it works

From day one to every day after.

A typical journey through Regulatory Intelligence — from onboarding to steady-state operations.

1

2

3

4

Monitor

Continuous automated monitoring of authority websites, document repositories and official journals. AI classifies documents by type and PV relevance.

Alert

Product-matched alerts dispatched to configured teams within 4 hours. Smart briefings summarise what changed and why it matters.

Assess

Product team conducts structured impact assessment: labelling impact, aggregate report obligations, signal implications, correspondence needed.

Act

Actions assigned with owners and deadlines. Progress tracked in the audit record. PSUR obligations auto-updated when new requirements are confirmed.

See It in Action

Watch Qualitus in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

Integrations

Connects where you need it to.

Regulatory Intelligence is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

RMP

Regulatory updates trigger RMP reviews

ICSR

Labelling changes feed expectedness assessment

Qualitus

Actions tracked in CAPA system

Signum

HA signal queries linked to signal records

Compliant with

GVP Module VII (PSUR)

GVP Module V (RMP)