Pharmaceutical promotional review workflow guide

Make the submission complete before review starts

Ask the requester to define the audience, market, product, channel and planned use. Identify the business owner and give the item a stable reference. Include the draft, supporting references, applicable product information and enough context for reviewers to see how the material will appear to the audience.

Use a completeness check to return missing information early. Keep the submitted version intact and record why an item was returned. Agree when the service clock starts so incomplete submissions are not counted in the same way as files ready for review.

Classify the activity under the applicable rules and company procedure. Non-promotional material can need examination or other controls; a label applied by the requester is not itself a decision about the route. Escalate uncertainty to the designated process owner.

A practical review-to-release workflow

The sequence below is a proposed operating model. Tailor the reviewer disciplines and order to the material and market. Name the person accountable at each hand-off and agree how absence, rework and urgent requests are handled.

Keep review and certification distinct

For promotional material within its scope, ABPI Code Clause 8.1 requires certification of the final form before issue. The certifier must meet the specified professional requirements and must not be the person who developed the material. Clause 8 also addresses electronic certification and final-form checks. Clause 8.6 requires retention of certificates and accompanying records for at least three years after final use.

Consult the full clause and supplementary information for the relevant material and signatory arrangements. A completed review task, automated green status or shared-service quality check should not be labelled certification. Make the different decisions explicit in the system and in user training.

Define the record at each hand-off

Use one item identifier with clearly numbered versions. Link comments and decisions to the version reviewed rather than storing them in an unconnected email chain. Record who made the decision, when it was made and what conditions remained.

Before release, compare the actual output with the authorised material. For digital content, the review context may include linked pages, navigation and the way content is displayed. Agree how a change is assessed and when the item must return to review.

Plan withdrawal before first use. Identify who can remove the item from active channels and how copies held by agencies or field teams are handled. Keep enough information to locate the retained record after staff changes. A document expiry date alone does not show that distribution stopped.

Automate coordination with controlled decision rights

Useful automation starts with predictable administrative tasks: checking required fields, assigning queues, sending reminders, identifying stale versions and assembling a history of actions. Define required permissions and prevent a changed document from inheriting an earlier version’s release state.

If AI supports a preliminary check, show its output as a suggestion for a qualified reviewer. Decide what content it can access, what evidence it must display and how errors are reported. Keep accountable decisions with the authorised people and preserve the material they actually reviewed.

• Test that an author cannot bypass an independent decision through a role change.
• Test what happens when content changes after a reviewer has completed a task.
• Test urgent requests, delegated cover and unavailable reviewers.
• Test withdrawal, expired access and recovery of an archived item.
• Agree how workflow changes are approved, tested and communicated to users.

Design the shared-service boundary

A shared service can coordinate intake, perform agreed review activities and maintain records within the company’s procedures. Write down the permitted scope, required expertise, escalation routes and decisions retained by the company. Where certification support is part of the engagement, confirm the applicable qualifications and formal arrangements separately.

Run a calibration exercise before taking routine volume. Give the internal team and service team the same sample and compare their comments, escalation choices and documentation. Resolve differences in interpretation before they become repeated rework.

Use a balanced set of service measures: submission completeness, review time by stage, reasons for rework, unresolved questions and withdrawal completion. Avoid rewarding turnaround alone. Review the reasons behind repeated queries and decide whether the fix belongs in the briefing, training, procedure or system.

Use the workflow checklist

Download the checklist and use one copy per workflow design or process review. Record the proposed owner, evidence location, status and unresolved action for each checkpoint. Adapt the suggested steps to your materials and markets before using it operationally.

The workbook is a manual planning record with no certification functionality. Keep live review decisions and controlled assets in the company-approved system. Eunomia can help map that process, build the workflow and provide shared-service support around it.

Evidence from a materials review engagement

Eunomia’s published shared-service case study reports review turnaround falling from 5 days to 2 days and review cycles from 4 to 2. These engagement-specific results illustrate the operating model; they are not a guaranteed outcome.

Read the case study and original evidence.

The people behind the support

Explore the roles and experience of Eunomia’s compliance team and identify the expertise relevant to your markets and operating model.