Your Pharma Playbook
The most regulated industry comes with no implementation manual.
We’re changing that.
Sound familiar?
E6(R3) changed the rules.
Quality-by-design, critical-to-quality factors, risk-based oversight — “we’ve always done it this way” is now a finding. Every sponsor needs a gap analysis, updated SOPs, and a trained team. Many are improvising all three.
Your CRO runs the trial. You own the consequences.
Regulators are explicit: you can delegate the work, but never the accountability. When the inspection comes, it comes to you.
The triple constraint is the triple threat.
Fast, inspection-ready, and resource-sparing — you’re expected to deliver all three. You carry the same regulatory obligations as big pharma without the department behind you. Picking two isn’t an option.
THE FIX?
Sound principles.
Stronger execution.
Decades of practical experience distilled into tools and techniques to make you more compliant AND efficient.
The how, already built.
Regulatory expectations turned into working tools.
Deploy the same day.
Download, tailor and put it to work -- with guides.
Built by operators, not theorists.
Average 20+ years across Sponsors, CROs and Sites.
Start free.
Articles, videos, and select assets. No gate, no pitch.
Three ways to
Work with us.
Whether you want to learn, get tools, or bring in expert support — we meet you where you are.
01
Learn on your terms.
Build your knowledge with free, practical resources.
- Articles and how-to guides
- YouTube videos and explainers
- Tools and templates to get you started
02
Get the right tools.
Download practical playbooks, templates, and guidance you can put to work right away.
- Inspection-ready playbooks
- Templates, trackers, and checklists
- Step-by-step instructions
03
Bring in expert support.
Leverage our experience to solve complex challenges and move forward with confidence.
- Consulting and project support
- Fractional resources when you need them
- Coaching to build internal capability
FEATURED PLAYBOOKS
Pick your play.
Ready-to-use playbooks, built from real-world experience so you can move faster and stay inspection-ready.
Sponsor Readiness: E6(R3) Annex 1
Everything a sponsor needs to run to E6(R3): quality by design at protocol stage, vendor oversight that survives a transfer of obligations, a data trail you can defend, and the decks to train it in.
11 kits
Singly or whole
122 documents
Plug in and use
Built for E6(R3)
Inspection-ready
Covers: QbD & CtQ factors · QTLs & risk registers · Vendor oversight · Data life-cycle & audit trail · Decentralised trials · Leadership & site training
Site Readiness: E6(R3) Annex 1
Everything a site needs to run to E6(R3): SOPs that match how the site actually works, delegation and consent you can evidence, IP and source data that hold up, and essential records an inspector can follow.
11 kits
Singly or whole
Built for E6(R3)
Inspection-ready
Delegation
Who does what
Covers: Site SOPs & training · Informed consent · IP management · Source data · Essential records · Inspection readiness
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