RegXtrakt

One platform for life science compliance-Regulatory at the core,Quality, Safety & Labelling connected. First filing to lifelong maintenance.

[RegXtrakt @RegXtrakt__]

Regulatory recap
• IN-KA: Recalls 3 Docetaxel batches for cold-chain excursion
• UK: Use filters during parenteral nutrition administration
• IN-CEN: Capecitabine 500mg not of standar…

Real-time regulatory intelligence with RegXtrakt
#PharmaRegulatory #RegulatoryIntelligence

[RegXtrakt @RegXtrakt__]

Regulators don't ask "did you file the case?"

They ask "what did you DO about it?"

RegXtrakt Safety ties every case and signal to the downstream actions — variations, label updates, communications — in one traceable thread.

#DrugSafety #Compliance #Pharma

[Aditya Tallapragada @aditya49]

静的な文書中心のコンプライアンスから、データ駆動の動的な継続的ガバナンスへ。SBOMからAIBOMへの進化はまさにその象徴で、AI時代はモデルや学習データの来歴まで「生きた証跡」として管理することが求められますね。#sbom #aibom #security #medicaldevices

[RegXtrakt @RegXtrakt__]

Case intake → assessment → reporting → signal → action.

Most PV tools stop at "reported."

RegXtrakt keeps going: the signal connects to the product, the market, the label and the registration it affects.

Safety intelligence, not just safety filing.

#Pharmacovigilance #PV

[RegXtrakt @RegXtrakt__]

A safety signal isn't just a PV problem. It's a labelling change, a variation, sometimes a market action.

RegXtrakt Safety lives on the same core as Regulatory — a signal lands in the same record your renewals are built from.

#Pharmacovigilance #DrugSafety #RegTech

[RegXtrakt @RegXtrakt__]

Your QMS and your regulatory system disagree about a product.

Which one is right?

Wrong question. There should only be ONE record.

In RegXtrakt, Quality runs on the same core as Regulatory — one product, one truth.

#QualityManagement #RegTech #Pharma

[RegXtrakt @RegXtrakt__]

Audit prep, two ways:

❌ Two weeks of hunting evidence across drives, emails and binders

✅ Open RegXtrakt: every SOP, CAPA, change control & training record already linked to the products and markets it covers

Which audit do you want?

#QMS #Compliance #LifeSciences

[RegXtrakt @RegXtrakt__]

A CAPA closes in your QMS. Does your registration file know?

In RegXtrakt, Quality isn't a silo — it reads product & market context from the Regulatory core, and the Dossier Compiler feeds evidence back into your submissions.

#QMS #QualityManagement #RegTech

[RegXtrakt @RegXtrakt__]

Weekly pharma regulatory updates
• IN-KA: Recalls 3 Docetaxel batches after cold-chain excursion
• UK: MHRA warns of hip implant metal-wear risks
• UK: Quarantine/dispose all NGPod pH…

Real-time regulatory intelligence with RegXtrakt
#PharmaRegulatory #RegulatoryIntelligence

[RegXtrakt @RegXtrakt__]

Pharma regulatory updates
• IN-CEN: Lenalidomide SPC 25mg capsules approved for manufacture and marketing
• UK: MHRA warns of metal wear and revision-surgery risk with cobalt-chrome mo…

Real-time regulatory intelligence with RegXtrakt
#PharmaRegulatory #RegulatoryIntelligence

[RegXtrakt @RegXtrakt__]

Regulatory intelligence isn't a newsletter.

It's knowing — the moment guidance changes — which of YOUR products, in which markets, are affected, and what to do next.

RegXtrakt connects authority updates to your actual portfolio.

#RegulatoryIntelligence #Pharma #MedTech

[RegXtrakt @RegXtrakt__]

Your product portfolio, as a living map:

📍 Every registration, by market
📅 Every renewal & obligation, on a timeline
📄 Every submission & document, versioned
🔔 Nothing due tomorrow that you learn about tomorrow

That's RegXtrakt Regulatory.

#RegTech #Pharma

[RegXtrakt @RegXtrakt__]

Where is product X registered? What's due next quarter? Which dossier version did we submit?

If answering that takes a meeting, you don't have a system of record.

RegXtrakt Regulatory: every product, market, obligation & document — one view.

#RegulatoryAffairs #RegTech

[RegXtrakt @RegXtrakt__]

Pharma regulatory updates
• UK: Astral ventilator safety alert
• IN-KA: Docetaxel batch recall
• UK: Fingolimod Class 2 recall

Real-time regulatory intelligence with RegXtrakt
#PharmaRegulatory #RegulatoryIntelligence

[RegXtrakt @RegXtrakt__]

Pharmaceutical regulatory updates
• IN-CEN: Lenalidomide SPC 25mg approved
• UK: Do not use infant rectal catheters; dispose
• UK: Fingolimod Zentiva 0.5mg recalled for metal particles

Real-time regulatory intelligence with RegXtrakt
#PharmaRegulatory #RegulatoryIntelligence

[RegXtrakt @RegXtrakt__]

⚠️ UK · Safety
Class 2 recall of Fingolimod Zentiva 0.5 mg Capsules over potential metal particle contamination
💡 The Class 2 recall concerns one fingolimod batch due to potential met…

Real-time regulatory intelligence with RegXtrakt
#PharmaRegulatory #RegulatoryIntelligence

[The Kobeissi Letter @KobeissiLetter]

BREAKING: Moderna stock, $MRNA, surges over +110% after announcing the first ever positive Phase 3 results for a personalized cancer vaccine.

[aktiv8 @Aktiv8__]

Embed regulatory strategy into cell and gene therapy programs from day one. Early regulatory alignment de-risks assets, clarifies development pathways, and strengthens deal terms — making programs more investable and attractive for par…

Track biotech catalysts & deals on aKTIV8

[RegXtrakt @RegXtrakt__]

Where is product X registered? What's due next quarter? Which dossier version did we submit?

If answering that takes a meeting, you don't have a system of record.

RegXtrakt Regulatory: every product, market, obligation & document — one view.

#RegulatoryAffairs #RegTech

[aktiv8 @Aktiv8__]

Novartis India names Dr. Chetan P. Head – Medical, Regulatory & PV.
Centralizing medical, regulatory and pharmacovigilance leadership can streamline regulator engagement and safety oversight, lowering execution risk for dealmaking and…

Track biotech catalysts & deals on aKTIV8