In this timeline we show when to start what, so you submit on time, inspection-ready.
THE SETUP
T0 = BLA/MAA Submission Target Date
Work backwards from your planned submission.
If you're starting PV system setup at T0-3 months: you're already behind.
If you're starting at T0-6 months: you'll make it, barely, stress and gaps might happen.
If you're starting at T0-12 months: you'll submit confidently, inspection-ready, with buffer.
This page shows the T0-6 month critical path. For optimal T0-12 month timeline, book consultation.
THE 6-MONTH CRITICAL PATH
Visual Timeline (Horizontal Gantt-Style)
T0-6mo ────────────────────────────────────────────────→ T0 (MAA Submission)
│
├─ Week 1: Project Kick-off
├─ Week 2: EU QPPV Assigned
├─ Month 1: SOP Development Starts
├─ Month 1.5: PSMF + SPS Creation Begins
├─ Month 2: RMP Drafting Begins
├─ Month 2.5: Global Literature Monitoring Setup
├─ Month 3: GLM Live Screening Starts
├─ Month 4: SOPs Finalized & Training Complete
├─ Month 4: RMP Finalized
├─ Month 4: Signal Management Strategy Setup
├─ Month 5: PSMF v1.0 Finalized
├─ Month 5: EudraVigilance Registration
├─ Month 5: Thorough MAA Package Review by QPPV
└─ Month 6: MAA SUBMISSION READINESS
MONTH-BY-MONTH BREAKDOWN
T0 (BLA Submission in US or decision to submit MAA in EU)
Milestone: Regulatory clock starts ticking on post-marketing obligations.
Action: Confirm submission date; initiate PV workstream.
T0 + Week 1: Project Kick-off
Deliverable: Project charter, roles/responsibilities matrix, timeline confirmation.
Activities:
- Align internal stakeholders (Reg Affairs, Clinical, Quality, Medical)
- Confirm QPPV assignment timeline
- Lock submission package delivery dates from clinical team
- Budget final PV setup costs
Why it matters: Internal coordination breaks down when roles aren't clear.
T0 + Week 2: EU QPPV Assigned & Onboarded
Deliverable: QPPV CV, signed contract, EudraVigilance registration initiated.
Regulatory requirement: GVP Module I mandates QPPV oversight of PV system before operational.
Critical: QPPV must be EU-based and qualified.
Common mistake: Assuming US QPPV qualifies for EU. They don't.
T0 + 1 Month: SOP Development/Adaptation
Deliverable: Draft SOPs for safety data management, expedited reporting, signal management, quality management.
Why it matters: SOPs must govern PV system before MAA submission. Inspectors audit SOP compliance.
Timeline reality: SOP development takes 8-12 weeks if starting from scratch. This is why T0-6 months is tight.
Our approach: We adapt template SOPs to your operations in 4 weeks.
T0 + 1.5 Months: PSMF + SPS Creation Begins
Deliverable: Draft Pharmacovigilance System Master File (PSMF) and Summary of Pharmacovigilance System (SPS).
Regulatory requirement: GVP Module II, documents structure and functionality of PV system.
Content includes:
QPPV details and deputization
PV system organizational structure
Database description
Country-specific requirements
SOP index
Quality system overview
Why this takes time: Requires input from multiple functions (IT, Quality, Reg Affairs, Clinical). Coordination = bottleneck.
T0 + 2 Months: RMP Drafting Begins
Deliverable: Draft Risk Management Plan for MAA dossier.
Components:
Safety specification (identified/potential risks)
Pharmacovigilance plan (routine/additional activities)
Risk minimization measures
Plans for post-authorization efficacy studies (if applicable)
Why start at T0-4 months: RMP requires clinical data synthesis, medical writing, regulatory strategy alignment. Rushed RMPs get questioned in Day 120 responses.
Time-saver: If you built dev-RMP during trials (our clinical safety approach), this step takes 3-4 weeks instead of 12.
T0 + 2.5 Months: Global Literature Monitoring Setup
Deliverable: GLM vendor contract, search strategy validated, screening workflow operational.
Regulatory requirement: Required for safety data collection pre- and post-approval.
Timeline note: Must be functional before MAA because PSUR timelines start from approval date—you need historical baseline.
Common mistake: Starting GLM at approval. You're then 6 months behind on data collection for first PSUR.
T0 + 3 Months: GLM Live Screening Begins
Deliverable: Weekly literature screening operational; case processing workflow live.
Why it matters: Captures safety signals between MAA submission and approval—feeds into benefit-risk narrative during regulatory review.
Inspection point: Regulators check GLM audit trail during PV inspections.
T0 + 4 Months: SOPs Completed & Training Done
Deliverable: Final SOPs approved; staff training records complete.
Regulatory requirement: GVP Module I—staff must be trained before performing PV activities.
Training scope:
All PV personnel (in-house + vendors)
Role-specific (QPPV, case processing, medical review, quality)
Documented with signature/date
Inspection point: Training records are first document requested during PV audits.
T0 + 4 Months: RMP Finalized
Deliverable: RMP ready for MAA dossier inclusion (Module 1.8.2).
Quality check: QPPV final review confirming:
Safety specification aligns with clinical data
Pharmacovigilance plan is feasible post-approval
Risk minimization measures are implementable
Common mistake: RMP not reviewed by QPPV until after MAA submission—leads to Day 120 questions about feasibility.
T0 + 4 Months: Signal Management Strategy Setup
Deliverable: Signal detection methodology documented; evaluation framework operational.
Regulatory requirement: GVP Module IX—establishes how you'll detect, evaluate, document signals post-approval.
Why now: Signal management must be functional at approval, not started after approval.
What this includes:
Signal detection methods (case review, literature, registries, clinical trials)
Evaluation criteria (disproportionality analysis, clinical assessment)
Documentation standards (signal evaluation reports)
Escalation pathways (to QPPV, to regulatory authorities)
Inspection point: Regulators assess whether signal management is proactive or reactive.
T0 + 5 Months: PSMF v1.0 Finalized
Deliverable: PSMF ready for MAA submission; entered into xEVMPD (Master File Location).
Regulatory requirement: PSMF must be referenced in MAA dossier and available for inspection.
Quality assurance: Final review by QPPV and Quality function.
Version control: PSMF is living document—must be updated within 2 weeks of any system changes post-approval.
T0 + 5 Months: EudraVigilance Setup Complete
Deliverable:
Organization registered in EudraVigilance
All users assigned necessary roles
PSMF entered into xEVMPD
Test ICSR submission successful
Why it matters: You cannot submit ICSRs to EudraVigilance without completed registration. Approval = immediate reporting obligations.
Timeline risk: EudraVigilance registration can take 2-4 weeks due to technical validation steps.
Common mistake: Waiting until approval to register. First SUSAR post-approval creates scramble.
T0 + 5 Months: Thorough Review of MAA Submission Package
Deliverable: QPPV review memo covering Module 1 (RMP, PSMF, SPS), Module 2 (Clinical Summary safety sections), Module 5 (CSR safety data).
Why critical: QPPV signs off that PV system can support post-authorization obligations described in RMP.
What QPPV reviews:
Consistency between RMP, PSMF, and clinical data
Feasibility of proposed pharmacovigilance activities
Completeness of safety specification
Signal evaluation plan adequacy
Inspection protection: If inspector questions PV system capability, you have documented QPPV review showing it was assessed.
T0 + 6 Months: MAA Submission Readiness
Milestone: All PV documentation complete, validated, inspection-ready.
Checklist:
✅ EU QPPV assigned with signed contract
✅ PSMF finalized and entered in xEVMPD
✅ RMP finalized in MAA dossier
✅ SOPs complete with training records
✅ EudraVigilance registration active
✅ Global Literature Monitoring operational
✅ Signal management framework documented
✅ Safety database validated and audit-ready
✅ QPPV review memo in submission file
Confidence level: You can submit knowing PV system is compliant, not hoping it passes inspection.
WHAT HAPPENS IF YOU START LATE?
T0-3 Month Scenario (Common Mistake)
Reality check: You cannot complete this scope in 3 months without gaps.
What gets sacrificed:
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GLM baseline data (no historical literature surveillance)
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SOP training (rushed or incomplete)
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Signal management strategy (documented but not operationalized)
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RMP quality (cobbled together, not strategy-driven)
Inspection risk: 17% of survey respondents received PV-related inspection findings. Late starts are primary cause.
Timeline impact: Day 120 questions about PV system often extend approval by 3-6 months.
THE T0-12 MONTH ADVANTAGE
Why Smart Teams Start at 12 Months
Buffer for:
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SOP iteration (vs one-shot draft)
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Staff training in phases (not crash course)
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Mock inspection and gap remediation
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RMP refinement as late-stage trial data emerges
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Database migration if needed (9-12 month process)
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Signal management pilot testing before approval
Stress reduction: No firefighting. No weekend work. No "will we make it?" anxiety.
Cost advantage: Rushed timelines = premium fees for expedited work. Planned timelines = standard rates.
SPECIALIZED SUPPORT = FASTER EXECUTION
Why In-House Teams Struggle with This Timeline
Bandwidth reality: PV system setup is not a part-time project alongside trial execution.
Typical in-house scenario:
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Head of Clinical Ops wearing QPPV hat (not qualified)
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Regulatory Affairs writing RMP (not their expertise)
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IT selecting database without PV input
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Quality auditing SOPs they didn't write
Result: Fragmented execution, missed dependencies, timeline slips.
How Specialized PV Accelerates
Integrated execution:
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QPPV drives entire workstream (no coordination tax)
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SOPs adapted from GVP-compliant templates (4 weeks vs 12)
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RMP authored by MD/PharmD (regulatory submission experience)
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EudraVigilance setup by people who've done it 50+ times
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Signal management framework deployed, not invented
Timeline reality: We complete this scope in 5 months when necessary because we have the infrastructure.
CASE EXAMPLE
Real Timeline Impact (Anonymized)
Client: Phase III oncology biotech, planning EU MAA
Original plan: Start PV setup at T0-3 months
Our consultation: Started at T0-8 months instead
Outcome:
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MAA submitted on time with zero PV documentation deficiencies
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EMA Day 120 questions: ZERO related to PV system
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Approval granted without timeline extension
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First post-approval inspection (Month 9): No findings
What they avoided: 61% of EU-bound companies cite QPPV availability as bottleneck. Starting early locked in QPPV before shortage intensified.
Quote: "If we'd started at 3 months like planned, we'd still be scrambling on EudraVigilance setup when approval came. Instead we were ready Day 1." — VP Regulatory Affairs
YOUR NEXT STEP
Get Your Personalized MA Prep Timeline
30-minute scoping call covers:
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Your target submission date (T0)
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Current PV infrastructure status
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Gap analysis (what's missing)
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Customized timeline (6, 9, or 12-month track)
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Budget scoping
Reach Out to Book a Consultation
FREQUENTLY ASKED QUESTIONS
Q: Can we start at T0-4 months and still make it? A: Possibly, but with gaps. GLM baseline data will be short. SOP training may be rushed. Signal management will be documented but not fully operationalized. Inspection risk increases.
Q: Do we need specialized PV provider or can CRO do this? A: Depends. If your CRO has EU GVP expertise, dedicated EU QPPV, and has done 10+ MAA PV setups, they can execute. Most trial-focused CROs don't. Our survey: 94% of EU-bound biotechs cite GVP compliance as top challenge when using US-focused CROs.
Q: What if we're doing US BLA first, EU MAA later? A: US BLA has lighter PV setup requirements (no PSMF, no GVP Modules). But if EU is on roadmap, build to EU standard from start—avoids system overhaul later.
Q: Can we use your QPPV but handle other parts in-house? A: Yes. Hybrid model works if you have internal bandwidth for SOP writing, training coordination, and EudraVigilance setup. QPPV oversight is the non-negotiable piece.
Q: How often does MA timeline slip due to PV gaps? A: Our data: 21% of survey respondents experienced delayed submissions due to PV documentation gaps. EMA Day 120 questions about PV system extend approval by 3-6 months on average.