Practical PV insights
No jargon for jargon's sake. No generic compliance checklists. Straight answers to the questions small pharma and biotech teams actually ask.
The hidden cost of outsourcing PV to a large CRO
Large CROs offer full-service PV at headline prices that look reasonable — until you see the out-of-scope charges, junior staffing, and average 14-day ICSR turnaround times that make inspections uncomfortable.
What is a QPPV and does your biotech need one?
The Qualified Person for Pharmacovigilance is a legal requirement for any company holding an EU marketing authorisation — but QPPVs are expensive, scarce, and poorly understood by most startup leadership teams.
Do you need pharmacovigilance before your Phase 1 IND?
Most founders assume PV starts after approval. In reality, the FDA requires a functioning safety system before you enrol your first patient — and the clock starts at IND submission.
What does a fractional VP Pharmacovigilance actually do? A complete guide
Fractional VP of Drug Safety is not a vague consulting arrangement. It is a specific, accountable role with named responsibility in your PSMF. Here is exactly what it involves — and when it makes sense.
5 SUSAR reporting mistakes early-stage biotechs make — and how to avoid them
Incorrect or late SUSAR reporting is one of the most common GCP findings at FDA and EMA inspections. These five mistakes show up repeatedly at companies running their first clinical trials.
The EU Risk Management Plan: what early-stage pharma needs to know
An EU-RMP is required for every new EU Marketing Authorisation Application. Most early-stage companies first encounter it 6 months before their MAA — far too late. Here is when to start and what it must contain.
IND safety reporting timelines: the 7-day and 15-day rules explained
Missing an IND safety reporting deadline can trigger an FDA clinical hold. Most Phase 1 sponsors understand the rules in theory but make practical mistakes applying them. Here is a clear guide to counting days correctly.
EMA pharmacovigilance inspection readiness: what small biotechs consistently get wrong
EMA conducts routine PV inspections of marketing authorisation holders — and triggered inspections when something goes wrong. Small biotechs consistently make the same five mistakes. Here is how to avoid them.
How to set up EudraVigilance access as a small EU clinical trial sponsor
If you are running a clinical trial in the EU, you need EudraVigilance access to submit SUSARs. The setup process is bureaucratic and takes 8-12 weeks. Here is exactly how to do it before your first patient in.
The DSUR explained: what Phase 1 and Phase 2 sponsors must know
The Development Safety Update Report is an annual regulatory requirement that most Phase 1 sponsors discover for the first time when they have already missed the first deadline. Here is what it contains and when it is due.
Signal detection in small pharma: what you actually need to do
Signal detection is not just a Big Pharma activity. Phase 2 sponsors have a regulatory obligation to detect, assess, and act on safety signals. Here is a practical framework for companies with limited resources.
ICSR processing: a practical guide for small pharma sponsors
Individual Case Safety Reports are the backbone of pharmacovigilance. Here is what small pharma and biotech sponsors actually need to know about collecting, assessing, and submitting ICSRs to FDA and EMA.
PSMF: what it is, what goes in it, and why your biotech needs one
The Pharmacovigilance System Master File is a legal requirement for EU marketing authorisation holders. In practice, every clinical-stage company doing EU trials should have one. Here is exactly what goes in it.