Genedrift

08/20/2025

QPPV in Kenya: The Non-Negotiable Link Between Safety and Compliance”

📢 Kenya’s Pharmacy and Poisons Board (PPB) has made it clear—Marketing Authorization Holders (MAHs) must have a resident, Board-recognized Qualified Person for Pharmacovigilance (QPPV) to safeguard product safety and regulatory compliance.

🔍 Key compliance essentials:

🧾 Permanent QPPV appointment—must reside in Kenya and be accredited by PPB.

🎓 Qualifications—Bachelor’s in Pharmacy + GVP training (refresher every 2 years).

🛡 Core responsibilities include:

Maintaining the Pharmacovigilance System Master File (PSMF)

Oversight of product safety profiles and emerging safety concerns

Adverse event reporting within PPB timelines

Submission of PSURs/PBRERs, RMPs, and post-market study reports

👥 Back-up QPPV—mandatory, equally qualified, and also resident in Kenya.

📑 Outsourcing allowed—but limited to 5 companies per QPPV and with full MAH accountability.

💡 Non-compliance risks:

Critical breaches can trigger product recalls, license suspension, urgent safety restrictions, and public blacklisting.

📊 At Genedrift, we help MAHs set up compliant QPPV structures—avoiding costly sanctions and ensuring uninterrupted market presence.

📲 Secure your PV compliance—speak to our team today.


✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

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Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/19/2025

“60 Working Days or 60-Month Budget Shock?”

Late-night finance call: “We budgeted under the old 2001 fees—new AO 2024-0016 rates blow our P&L.”

Bullet shocks:

🏷️ Fee hike ranges 15-40 % once freeze lifts.

📅 60-day window ticks from 11 Jun 2025—no guarantee of extension.

💳 Orders of payment issued under the new AO stand—no refunds.

🔄 Variation dossiers filed after the freeze face dual back-fees.
💡 Genedrift repackages your queue—pay 2001 rates, not 2024 spikes.


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✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

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Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/18/2025

✅ “Who answers the 2 a.m. safety call?” — Why your Indian QPPV can’t be a paper title
Picture this:
01:47 a.m. A tertiary-care hospital faxes an acute liver-injury report for your top oncology brand. CDSCO calls the hotline. No one picks up. By sunrise…

🛑 72-hour clock breached – serious ADR unreported; CDSCO issues show-cause notice.

📝 Spot inspection lands in 5 days – first question: “Where is the in-country QPPV’s log?”

🚫 Temporary suspension letter drafted – distributors yank stock, prescribers switch to a competitor.

All because the Pharmacovigilance Officer-in-Charge (PVOIC) — India’s equivalent of the EU QPPV — wasn’t truly 24/7.

Non-negotiables every Indian QPPV must check daily:

🔐 Real authority – documented power to halt batches, recall product, or escalate CAPA without “management approval.”

🛰️ Signal dashboard – literature, social, PSPs, call-centre feeds funnelled into one triage queue.

📊 ICSR & PSUR clock – automated alerts 48 h, 24 h, 6 h before regulatory cut-offs.

📂 PSMF on-demand – latest CV, job description, deputy delegation and training matrix at Section 1.

🕵️ Audit readiness – mock inspection findings closed ≤ 30 days; evidence folder mirrored in the cloud.

FOMO outcome:
Companies with a bullet-proof Indian QPPV sail through CDSCO audits and win hospital tenders faster. Laggers watch licence holds, budget blow-outs, and brand erosion.

💡 Genedrift’s “Standby-QPPV” suite:

Local resident QPPV & deputy placement – contracts signed in < 7 days.

PV command-centre build – signal triage + KPI dashboards live in 4 weeks.

Inspection drill – 1-day war-game, close gaps before regulators ring.

Answer the 2 a.m. call before it comes. Talk to Genedrift or apply for open QPPV roles today.





✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/15/2025

Celebrating 78 Years of Freedom and Progress – Happy Independence Day !🎉

On August 15th, 2025, we honour the courage, sacrifice, and vision of our freedom fighters who gave us this priceless gift of independence. As we raise our tricolour and sing the national anthem, let’s remember their dream of a united, prosperous, and harmonious nation.

Let’s cherish our rich culture and diversity, and commit to building the India of our dreams with honesty, hard work, and unity. Today isn’t just a day to celebrate our freedom—it’s a reminder of our responsibility to contribute towards a brighter future for every Indian.

🌟 “Freedom is our precious gift. Cheers to unity and diversity!”

Wishing everyone a very Happy Independence Day!

Genedrift
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Get in touch - cs@genedrift.com

08/14/2025

✅ Pharmacovigilance in India = timers that never pause ✅

Under CDSCO/PvPI, once a safety case hits Day 0, the clock starts and never stops: submit fatal or life-threatening, unexpected ADRs in 7 days (with follow-up in the next 8), all other serious, unexpected ADRs in 15 days, non-serious unexpected cases in 30 days (where applicable), and

Serious unexpected clinical-trial ADRs within 90 days via DSUR addenda. Miss one timer and you’re looking at a major observation; repeat misses put licences, tenders, and brand trust at risk.

How Genedrift keeps you on time:
Our “No-Late-Case” engine auto-stamps Day 0, drives 72/24/6-hour alerts to QPPV & deputy, surfaces literature cases before regulators do, and runs mock gateway drills so every ICSR lands cleanly.

Connect with Genedrift’s India PV desk or explore open QPPV roles today.



✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

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Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/13/2025

✅ India’s In-Country QPPV (🎯 PVOIC) — The One Signature That Keeps Your Product on Shelves

🚨 Marketing-Authorization Holders: CDSCO now expects every MAH to name a Pharmacovigilance Officer-in-Charge (PVOIC) — functionally the same as the EU’s QPPV — and to prove that person can steer the entire safety system 24/7. Skip a duty and your licence hangs in the balance.

What a fully-loaded Indian QPPV / PVOIC must own:

🛡️ System Authority – power to approve or block any safety-critical process, across affiliates and CROs.

📚 SOP & QMS Architect – drafts, signs and updates every pharmacovigilance SOP; drives continuous quality improvements.

🎓 Training Commander – designs PV curricula, tracks completion, and re-tests staff when the guidance updates.

🛰️ Data Sentinel – captures ADRs from call centres, HCPs, literature, social media, PSPs… no source left behind.

🏷️ ICSR & PSUR Captain – oversees case processing, signal detection, CAPA, periodic safety reporting and emergent risk comms.

📞 24/7 Regulator Hotline – resident in India, reachable day or night for CDSCO or PvPI inspections and queries.

🔄 Delegation Guardrails – maintains a documented back-up (Deputy QPPV) with identical competence for seamless cover.

FOMO reality check:

No in-country QPPV = inspection fail → product suspension.

Training logs missing? Expect a remediation order.

Delayed PSUR? Penalties + public safety notice.

A rival with a bullet-proof QPPV wins hospital confidence while you scramble for CAPAs.

💡 How Genedrift secures your compliance:

Talent tap – pre-qualified QPPV / Deputy QPPV roster, ready to slot into your licence.

SOP overhaul – end-to-end gap audit vs latest PvPI guidance, rewritten in 15 days.

24-month QMS roadmap – KPIs, audit calendar and automation triggers so your PV engine never stalls.

Don’t let a missing signature stall a multi-crore portfolio. Connect with Genedrift’s India PV desk or explore open QPPV roles today.



✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/12/2025

🇵🇭 Pay High or File Fast—No Refunds Guaranteed

⏳ Fees already paid at new AO 2024-0016 levels stay—no claw-back.

🔍 Any future variation filed after 60-day freeze auto-prices at the higher matrix.

💡 Best option? Submit all variations now while the rollback holds.

Genedrift reprices budgets, completes screening in one shot and submits in 72 hrs



genedrift.com/careers

✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/11/2025

“Mercaptopurine Safety Alert—Miss the Leaflet Update, Face a Recall”
🚨 Letter 衛授食字第 1131408628A 號 : Taiwan’s MOHW orders an urgent risk-communication update for all drugs containing mercaptopurine, azathioprine, or febuxostat. Delay, and your product could vanish from shelves.

Key orders hidden in the fine print:

📜 New boxed warning on serious myelosuppression + TPMT/NUDT15 genotyping.

🖨️ Revised PI & outer-carton wording must reach TFDA within 60 calendar days—no grace.

📲 Risk Communication Sheet to be e-mailed to HCPs & posted on company websites within 30 days.

🧪 Ongoing RMP commitments—extra safety-signal data due each quarter for 12 months.

🚫 Sell-through allowed but only with updated flyers inserted into existing stock.

FOMO reality check:

Miss the 60-day PI filing → TFDA can suspend your licence pending re-labelling.

Hospitals may switch formularies to compliant competitors; you lose ward share overnight.

💡 Genedrift’s “Risk-Alert” package:

- Draft bilingual warnings & genotyping guidance—ready for TFDA upload in 48 h.
- Coordinate emergency leaflet print-run & warehouse insertion.
- Push HCP e-blast + website banner before Day 30 timer expires.

Turn a safety crisis into a credibility win—update faster than the directive demands.



✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/08/2025

“ADR Portal Reset—Re-Register or Lose Your Reporting License”
🚨 Taiwan RA & PV leaders—FDA藥字第 1131409964 號 just forced a hard reboot of the National Adverse-Drug-Reaction (ADR) reporting system. Ignore it and your safety compliance goes dark.

What the 7 Aug 2024 letter really means:

🔐 All users must create a brand-new account—old log-ins die the moment you hit the portal.

🪪 Natural-person certificate + company certificate now mandatory; no dual-factor, no entry.

👤 Each firm needs one “Unit Administrator” who authenticates every staff account—skip this and the whole team is locked out.

🗳️ Upload format tightened—only PDF/A & JPG; the bot auto-kills “unknown” files.

🕒 ADR reports submitted offline will NOT count toward time-critical 15-day serious-case rules.

FOMO reality check:

Fail to re-register → zero access → missed 15-day clock → TFDA penalty & public notice.

Competitors who migrate today show real-time compliance while you scramble for certificates.

💡 Genedrift’s “Portal-Reboot” sprint:

Map natural-person & company certificates for every user.

Draft & submit Unit-Administrator paperwork in 24 h.

Dry-run uploads under the new file spec—green tick before auditors knock.

Don’t let a cyber-security upgrade become a revenue-security nightmare. Book your reboot slot now.



✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/07/2025

“ICH Q7 Lands—Quality-Unit or Quality-Crash?”
18 June 2025: NAFDAC’s new API GMP Guideline adopts ICH Q7 word-for-word.

Slip-ups that now earn majors:

🗂️ QA & QC merged with Production? Non-independent unit = observation #1.

🧽 Unvalidated cleaning matrix—three majors → licence suspension.

🕵️ Internal audit “when time allows”—expect inspector déjà vu in 12 months.

💡 Genedrift re-draws org-charts, scripts audit calendars, and gap-maps your plant to ICH grade—before regulators do.



✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/06/2025

“Screening-Clearance Stopwatch—Tick ▶ Draft = Casket”
🚨 Nigeria biotech leads—one missing PDF can slam a 240-work-day door on your biologic.

What blindsides teams on Day 1:

📤 Upload link is single-use—request it at vb.vbmrr@nafdac.gov.ng or your dossier never leaves Outlook.

🗂️ Each module = own folder in searchable PDF; mix files and the clearance bot auto-flags “unreadable.”

🔒 Screening-Clearance letter is the golden ticket—skip it and NAPAMS blocks your application at log-in.

⏳ Clock stops at every query; respond past 60 work-days and the system archives your file.

FOMO reality check: competitors who cleared screening in Q2 are already queuing import permits—your market slot won’t wait.

💡 Genedrift’s “Clearance-Sprint”: folder architecture templates → PDF searchability scan → email dispatch → confirmation in 48 h.






✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

08/05/2025

Think Your PQS Is Solid?
NAFDAC’s 2024 GMP Guide Adds 26 New ‘Must-Have’ Controls”

🚦 Under the revised GMP Guidelines (DER-GDL-019-03):

🏗️ Top management now bears explicit responsibility for an effective Pharmaceutical Quality System—no delegation.

📊 Annual Product Quality Reviews are mandatory for every dosage form you sell in Nigeria.

🔄 Change-control lapses feed straight into your risk score (and inspection frequency).

🧪 Cleaning validation must prove removal of residues before “test-until-clean” is even discussed.

🌡️ Water, HVAC & compressed gases require full IQ/OQ/PQ and on-going trend files.

❗ Non-compliance isn’t theoretical: heightened post-marketing surveillance has already triggered blacklists, suspensions, and fines for repeat offenders.



✅ No hidden hurdles
✅ No expensive delays
✅ Only smooth, stress-free "To the Market"

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.