SOPs, WIs & Governance That Actually Work
Practical, audit-ready approval frameworks that reduce rework, speed decisions, and keep ABPI risk under control—without creating bureaucracy.
- Fast turnaround • Practical documentation • Easy adoption
Clear end-to-end approval workflow (roles, handoffs, decision points)
Templates + checklists that make “signatory-ready” the default
Governance for meetings, digital, materials, grants and more
Built to fit your team’s reality—not a generic policy document
Optional rollout training + adoption support
We make processes work for you that are ABPI compliant as standard
What you’ll achieve
If approvals feel slow, inconsistent, or risky—this fixes the system, not just the symptoms.
- Fewer approval cycles with clearer standards and better inputs
- Consistent decisions across Marketing, Medical, Compliance, and Agencies
- Cleaner evidence trails (claims, substantiation, rationale, records)
- Audit-ready governance that reduces PMCPA and reputation risk
Promotional material approval SOP (job bag standards, substantiation rules)
Meetings & congress governance (incl. international congress activity)
Advisory board SOP/WI (classification, contracts, outputs, FMV process)
Digital & social media governance (web, email, social engagement rules)
Grants, donations & sponsorship SOP (process, documentation, transparency)
Withdrawal & archiving / certification records (traceability + compliance)
How it works
A lean methodology that delivers governance people will actually use.
We keep it simple: define the decisions, reduce ambiguity, and give teams tools that make compliance easier—not harder.
Diagnose + design the workflow
We map your current process, identify where rework and risk are created, then define a clean approval pathway: roles, decision points, evidence expectations, and required records.
• Map current vs target process
• Define “what good looks like” standards
• Remove duplication and vague handoffs
Build documents + rollout toolkit
You get SOPs/WIs, plus practical templates and checklists to drive adoption. Optional training ensures consistent use across functions and agencies.
Where needed, we align outputs to your internal systems (e.g., Veeva/approval platforms) and build an audit-friendly evidence trail.
SOP / WI document set (version-controlled, audit-ready)
RACI + roles/responsibilities
Step-by-step workflow (process map)
Templates: briefing form, claims table, evidence checklist, meeting pack checklist
“Signatory-ready standard” one-pager (rules of thumb + common pitfalls)
Optional: training deck + team rollout session
FAQ
Frequently Asked Questions
An SOP sets the “what and why” at a process level. A WI is the practical “how-to” with step-by-step actions, templates, and examples. Most teams need both for real adoption.
Yes. We design governance to work with your tools and workflows, including required records, sign-off steps, and evidence capture.
Usually the SOP is too generic, lacks clear standards (“what good looks like”), or doesn’t provide templates that improve inputs. We fix the decision rules, not just the wording.
Most impact comes from: claim/evidence standards, meetings governance (incl. ad boards), digital/social rules, and a clear audit trail for decision rationale and approvals.
Depends on scope. A single SOP/WI can be delivered quickly, while a joined-up governance suite takes longer. We agree a practical plan based on your priorities and deadlines.
Yes. Documentation alone doesn’t change behaviour. We can run a short rollout workshop to embed consistent application across functions and agencies.
Always. Templates drive consistency and reduce rework—briefing forms, claims tables, evidence checklists, meeting pack checklists, and signatory-ready standards.
Book a call and share your current pain points and any existing SOPs/WIs. I’ll propose the quickest route: fix one high-impact area or build a full governance kit.
Insights and more
News & PMCPA Cases
AI-Enabled MLR in Pharma: Governance First Guide
AI tools can enhance Medical affairs MLR workflows but pose governance challenges. It’s crucial to implement strict controls, maintain compliance with the ABPI Code, and ensure documented human oversight.
AstraZeneca: promotional meeting misclassified and LinkedIn ‘likes/reposts’ led to pre-authorisation promotion and public advertising concerns (AUTH/3729/1/23)
Six complaints against AstraZeneca. Breaches found for a UK meeting treated as non-promotional (certification/PI and ‘cure’ claims) and for LinkedIn engagement promoting an unlicensed medicine and a POM to the public.
Blurred boundaries: Lessons from the Eli Lilly Facebook Breast Cancer Ad (CASE/3869/12/23)
TL;DR: Even a globally reputable company using trusted partners can stumble into serious compliance breaches online. All pharma professionals should be proactive, transparent, and vigilant—especially with third-party digital campaigns. The future of ethical pharmaceutical advertising depends on it. For many in pharma, the digital landscape can feel like quicksand—seemingly solid
The ripple effect of a single click: What Moderna’s mRESVIA PMCPA case really teaches us
Ever wondered how something as innocent as a LinkedIn ‘like’ could pull an entire pharma company into PMCPA hot water? I once underestimated how quickly a digital echo can travel, but the Moderna mRESVIA PMCPA case showed the true power (and risk) of our online footprint. Let’s break down what
LinkedIn landmines: The hidden pitfalls of pharma social media
What 214 Social Media cases taught me about compliance risk I’ve just finished reviewing 214 PMCPA cases where social media played a role. The pattern is undeniable: LinkedIn and other platforms are now a leading source of ABPI Code breaches. And the worrying part? Most of these breaches started with
Beyond the headlines: What the Epidyolex Press Release ruling really teaches pharma teams
Let me take you behind the scenes of a Jazz Pharmaceuticals case that could have happened to any of us. In my early years as a final signatory I found myself agonising over whether mentioning a drug’s brand name too many times in a Press Release could result in a