Introduction

Pharmaceutical teams use Parakeet Risk to centralize regulatory intelligence from FDA and EMA, translate changes into actionable tasks, and deliver real‑time alerts in Slack and Microsoft Teams. Built for GMP-regulated environments, Parakeet enriches each signal with context, routes it to the right owner, and preserves a complete audit trail mapped to your QMS and CAPA workflows. See industry fit on our Pharma solution page and always‑on monitoring on Continuous Compliance.

What we monitor (FDA/EMA) and how it’s used

• FDA guidance issuances and updates, via the centralized Guidance Document search and CDER-specific filters, used to trigger policy/control reviews and gap analyses. citeturn0search1turn0search0

• FDA recalls, market withdrawals, and safety alerts to initiate change control, labeling checks, and field action readiness. citeturn0search2turn0search5

• FDA drug shortages (current/resolved), including DSS updates, to inform supply planning, allocation decisions, and alternative sourcing. citeturn0search4turn0search7

• EMA scientific guidelines (quality/nonclinical/clinical/biologicals) to align dossiers and validation plans with the latest EU expectations. citeturn1search3

• EMA Direct Healthcare Professional Communications (DHPCs) and agreed EU communication plans to drive safety notices, RMP updates, and HCP communications. citeturn1search0turn1search5

• EMA European Shortages Monitoring Platform (ESMP) and shortages catalogues to anticipate EU supply constraints and coordinate mitigation. citeturn1search6

• EMA newsletters/CTIS newsflashes and press materials to track procedural or system changes impacting trial submissions and post‑authorisation monitoring. citeturn1search7turn1search1

Alert cadence examples

Parakeet delivers both real‑time notices and scheduled digests, tuned per source and business risk.

Daily (real‑time or batched)

• New FDA guidance posted (e.g., CDER item) → trigger “policy/control review” task with owner and due date. citeturn0search1

• FDA safety recall for a relevant product class → open change‑control and notify labeling/quality leads. citeturn0search2

• FDA Drug Shortage entry status change (current→resolved or new listing) → notify supply planning and procurement. citeturn0search4

• EMA DHPC published for product/therapeutic area → notify safety/pharmacovigilance to update communications and RMP. citeturn1search0

Weekly digest

• “Guidance & Safety Weekly” summarizing FDA/EMA guidance issuances, shortage trends, and any DHPCs impacting the portfolio, with links to original notices and internal tasks. citeturn0search1turn0search4turn1search0

• “EU Regulatory Ops” summarizing new/updated EMA guidelines and CTIS newsflashes affecting trial submissions. citeturn1search3turn1search7

Message examples (Slack and Teams)

Parakeet posts directly to your collaboration tools; see integrations for Slack and Microsoft Teams.

Example Slack post

• Channel: #reg‑intel

• Title: FDA Guidance Issued — topic: Data Integrity in Analytical Methods

• Summary: New CDER guidance issued; effective upon publication. Impacted SOPs: QMS‑DOC‑014, LAB‑VAL‑022. Action: Complete gap analysis by Nov 12, 2025.

• Buttons: View Source • Create Tasks • Assign Owners

Example Teams post

• Team: Regulatory Affairs

• Card: EMA DHPC — Product: Aflibercept (Eylea); Signal: Higher risk of intraocular pressure increase with pre‑filled syringe.

• Linked Workflows: Labeling review; HCP comms approval; CAPA tracking.

• Buttons: Open in Parakeet • View DHPC • Start Change Control. citeturn1search5

Routing matrix (who gets what, where, and when)

Evidence handling and audit readiness

Parakeet stores the original notice, normalized metadata (issue date, status, product/class, geography), and the full decision trail (who triaged, what changed, when). Electronic records and signatures are managed in line with FDA’s 21 CFR Part 11 scope and enforcement guidance, including validation, audit trails, record retention, and copies in human‑readable formats. citeturn2search1turn2search0

Configuration highlights

• Sources and filters: limit by therapeutic areas, product keywords, regions, and dossier lifecycle stage; de‑duplicate cross‑posted items across sources.

• Workflows: map alerts to SOPs, CAPAs, and change controls in your existing QMS; assign SLAs and escalation paths.

• Delivery: choose Slack, Teams, WhatsApp, and Google Calendar reminders; configure quiet hours and digest windows. See Slack, Teams, WhatsApp, and Google Calendar integrations.

• Research assistance: use the Rosella AI Agent to summarize guidance diffs, draft policy redlines, and generate audit evidence packets; platform capabilities on Features.

Source list (authoritative)

• FDA — Search for Guidance Documents (sortable by issue date; supports email updates). citeturn0search1

• FDA — Recalls, Market Withdrawals & Safety Alerts. citeturn0search2

• FDA — Drug Shortages (current/resolved; DSS program). citeturn0search4turn0search7

• EMA — Scientific Guidelines (human medicines). citeturn1search3

• EMA — DHPCs (EU‑level HCP safety communications). citeturn1search0

• EMA — European Shortages Monitoring Platform (ESMP) and shortages catalogues. citeturn1search6

• EMA — Newsletters/CTIS newsflash. citeturn1search7

Get started

• Talk with our team to tailor the routing matrix and cadences for your portfolio on Pharma.

• Explore continuous monitoring and incident orchestration on Continuous Compliance.