SOPs, Work Instructions & Governance Design
End-to-end design or redesign of your materials governance framework — from review matrix and SOP writing to routing workflows, committee structures, and team training. Built to make you both compliant and faster.
Discuss Your Process →The problem
A poorly designed materials approval process does not just create inefficiency — it creates compliance risk. When the process is unclear, inconsistently applied, or undocumented, every review cycle becomes a negotiation and every inspection becomes a risk. These are the situations this service is designed to resolve.
Multiple review rounds are often a symptom of a poorly defined process, not poor materials. When the scope of each reviewer's input is not clearly defined, everyone reviews everything, comments accumulate on top of each other, and the material goes around again. The fix is process design, not harder work.
Without a documented review matrix, different people apply different standards to the same material type. Marketing believes a type of content does not need medical review. Medical believes it does. The signatory is the tiebreaker — every time. That is not a review process; it is a series of individual negotiations.
ABPI and MHRA inspectors specifically examine materials approval governance. They expect to see a documented process that is consistently followed and properly evidenced. If you cannot produce a clear SOP and demonstrate that it is being applied, the inspection conversation becomes very difficult very quickly.
Onboarding into a materials review process that exists only in institutional memory is slow, inconsistent, and error-prone. New joiners submit materials incorrectly, receive feedback that does not reference any written standard, and develop idiosyncratic habits that persist for years. A documented process solves this in weeks.
When the official approval process is slower than the business needs it to be, people find workarounds. A social media post goes live without review. A briefing document is circulated informally. A congress piece is approved verbally. Each of these is a compliance failure waiting to be examined. The solution is not stricter enforcement — it is a faster process.
Without a standard submission cover sheet and reference pack format, each submission arrives differently. Reviewers spend the first 20 minutes of every review establishing what they have been sent rather than reviewing it. Standardised submission templates eliminate this entirely.
What's included
This is not a template purchase. It is a full governance design engagement that produces documented processes your team understands, can follow consistently, and can demonstrate to an inspector. Templates are included as part of the engagement, not the sum of it.
Every engagement starts here. A structured review of your current approval process — how materials are submitted, who reviews them, what standards are applied, how decisions are documented, and where the bottlenecks and inconsistencies are. The audit findings drive everything that follows.
A clear, documented matrix defining which material types require review by which functions, in what sequence, and with what authority. Eliminates ambiguity about who reviews what, removes duplication of effort, and gives every reviewer a defined scope of input.
Written standard operating procedures for materials review and approval, compliant with pharmaceutical SOP formatting standards. Drafted in plain language your team can actually follow, with version control, effective date, and change history built in from the outset.
Role-specific work instructions for each function in the review process, plus submission cover sheet templates, reference pack format templates, and approval routing documentation templates. Everything a new team member needs to submit correctly from day one.
Documented standard timelines for each material type and review stage, with escalation procedures for urgent reviews and clear expectations for each reviewer. Gives commercial teams predictability and removes the sense that the review process is a black box with no expected exit date.
Practical training for all roles involved in the review process — submitters, reviewers, signatories, and approvers. Training is scenario-led and based on the new documentation. Every engagement ends with a team that knows how to use the process, not just a team that has one.
The difference
Process redesign has a measurable effect on review cycle times, submission quality, and team confidence. These are the differences organisations typically see within the first two months of implementing a redesigned governance framework.
How it works
The engagement follows a defined sequence. Each phase builds on the previous one — the process design is informed by the audit, the documentation is informed by the design, and the training is built around the documentation. Nothing is produced in isolation.
Structured review of the current approval process through stakeholder interviews and documentation review. Covers submission routes, reviewer scope, current timelines, pain points, near-misses, and the gap between what the process is supposed to be and what it actually is. A written audit report is produced with findings and priority recommendations.
Collaborative design of the new approval process — review matrix, routing logic, approval stages, committee structure if applicable, escalation routes, and standard timelines. Presented to key stakeholders for input before documentation begins. The design stage is iterative — it does not proceed to documentation until all functions are aligned.
Production of all governance documentation — SOP, role-specific work instructions, review matrix, standard approval timelines, submission cover sheet template, and reference pack format template. All documents formatted to pharmaceutical SOP standards with version control, review dates, and change history.
All documentation reviewed with key stakeholders — legal, medical, regulatory, and compliance. Revisions incorporated. Final versions issued in agreed format. Documentation signed off before training begins to ensure the team is trained on the final version, not a draft.
Practical, scenario-led training for all team members involved in the approval process — tailored by role. Submitters, reviewers, signatories, and approvers each trained on their specific responsibilities and how the new process works in practice. Training completion is documented.
A review session at 6-8 weeks post-implementation to assess how the new process is performing in practice, address any teething issues, and confirm that review cycle times and submission quality are improving as expected. Post-implementation review availability is discussed on the call.
What clients say
“Our average review cycle was 4.2 rounds. After the process redesign, it dropped to 1.8 within two months. The SOP did not just make us compliant — it made us faster. For the first time, commercial teams could plan a launch schedule and trust that materials would move through review at the speed they needed.”— Head of Regulatory Affairs, UK affiliate
“We had an ABPI inspection two months after implementing the new governance framework. The inspector specifically commented on the quality of our process documentation and the fact that it was clearly being followed in practice. That is not something you can fake — it required a process that actually worked.”— Medical Director, mid-size UK pharma company
Who this is for
Governance redesign has the highest return when the process problems are structural — not a question of individual effort or expertise. If your team is working hard but materials are still taking too long and the documentation is not where it needs to be, the structure is the problem.
ABPI and MHRA inspectors expect to see a documented, consistently applied materials approval process. If yours is not ready to be examined, this engagement is built for you.
If your average material goes through four or more review rounds before sign-off, the process is the problem — not the materials or the people. Redesign is the fix.
New UK market entrants who need to build a materials approval infrastructure from the ground up — compliant from the first day of promotional activity.
Companies that have received a PMCPA finding or adverse inspection outcome and need to rebuild their materials governance process as part of the remediation programme.
Where institutional knowledge is the only thing standing between a functional review process and chaos — documented governance is the only sustainable solution.
Where marketing is finding workarounds because the official process is too slow — the right response is a faster compliant process, not enforcement of a broken one.
Common questions
Yes, without exception. The process audit is the first phase of every engagement. No recommendations are made until the current state has been fully assessed — because a redesign that is not grounded in a clear understanding of what is actually happening is unlikely to address the real problems. The audit findings drive every subsequent design decision.
Typically six to eight weeks from the start of the audit to the completion of team training. The exact timeline depends on the complexity of the current process, the number of material types and stakeholder functions involved, and the speed at which the organisation can provide input and review documentation. The timeline is confirmed at the outset of the engagement.
Every engagement includes a full documentation set: the Materials Review SOP, role-specific work instructions for each function in the process, the review matrix, the standard approval timeline framework, a submission cover sheet template, and a reference pack format template. All documents are formatted to pharmaceutical SOP standards and are provided in editable format for ongoing version control by the organisation.
A post-implementation review session at six to eight weeks after training completion is included as standard — to assess process performance, address any issues that have emerged in practice, and confirm the metrics are moving in the right direction. Longer-term post-implementation support, including SOP review cycles and ongoing governance advisory, is available as an optional continuing engagement — discussed on the discovery call.
Book a discovery call to discuss your current process, the specific problems you are trying to solve, and how a governance redesign engagement can be scoped for your organisation.
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