Eunomia writes and updates compliance policies and standard operating procedures for pharmaceutical and biotech companies in the UK. We start from how your teams work, benchmark against the ABPI Code, EFPIA requirements and UK law, and draft lean, practical documents with clear owners, steps, records and review cycles.
Discuss this service
UK expertise · Practical delivery
For compliance and quality leaders in pharmaceutical and biotech companies in the UK: a first policy and SOP set for a company preparing to launch, a Code update, or harmonisation across markets after growth or an acquisition.
Policies copied from templates or from a previous company rarely match how teams actually operate. People work around them, and the evidence the procedure promises is never created. We write documents from the workflow outwards.
From requirements to action
Depending on the agreed scope, deliverables can include:
Our scope covers commercial healthcare compliance processes such as promotional review, HCP engagements, events, grants and disclosure. Related risk-assessment support can identify control gaps and owned actions. Automation support can connect evidence collection, approval routing, escalation and reporting while retaining accountable human review.
Bring the processes and countries in scope, your existing documents and templates, the systems teams use, and examples of gaps or workarounds. We agree whether the work is a new SOP set, an update or harmonisation across markets.
Discuss your requirementsWhat we can take on
What this gives you
Documents mapped to real workflows, so they can be followed and enforced
Clear owners, approval steps and records for each process
A review cycle that keeps documents current as rules change
The rules in the UK
Good SOPs turn code and legal requirements into steps and records. These are some of the requirements UK pharmaceutical SOPs most often have to deliver. Each summary links to its official source below.
Promotional material must not be issued unless its final form has been certified by one person on behalf of the company. Certificates and accompanying information must be preserved for at least three years after final use and produced on request from the MHRA or the PMCPA.
For arrangements within the Code’s scope, Clause 24 addresses legitimate need, selection, advance written contracting and reasonable remuneration reflecting fair market value, all of which an SOP has to turn into steps and records.
Transfers of value are disclosed annually, within six months of the end of each calendar year. Disclosures stay public for at least three years and records are kept for at least five, unless national law requires otherwise.
Related article
Crafting a high-quality pharmaceutical compliance policy. Our guide sets out Eunomia’s approach: as-is analysis, gap analysis against EFPIA, EMA, ABPI and EU requirements, workflow mapping, and tailored drafting with clear purpose, roles, process, monitoring and links to SOPs.
More reading: Audit readiness best practices · EFPIA Code Self-Assessment Checklist · Pharma Compliance Readiness Checklist
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, activity and counterparty in question. Sources checked September 2026.
Questions, answered
Start with structure, not a blank document. We analyse current documentation, workflows and governance; benchmark against the applicable codes and regulations; map the policy to real workflows; and draft lean text with purpose and scope, principles, roles, process, monitoring and links to SOPs.
Usually promotional materials review and certification, HCP engagement and contracted services, events and hospitality, grants and donations, and disclosure. For example, Clause 8 of the ABPI Code requires promotional material to be certified in its final form and certificates to be kept for at least three years after final use.
Yes. We review existing SOPs against the current Code and your activities, and update the steps, roles and records that need to change.
Yes. A common global SOP with documented local variations is often clearer than separate documents per country. Our local partners help identify where national rules differ.
Yes. Roll-out can include training, templates, workflow configuration and a review cycle with named owners.
Yes. SOP development can connect to our compliance automation services. We map process steps, responsibilities and evidence requirements before agreeing workflow support for evidence collection, approval routing, escalation or reporting. Accountable people retain review and decision responsibilities.
Yes. Related pharmaceutical compliance risk-assessment support can identify activity-specific risks, control gaps and actions with named owners. Findings can inform the SOP steps, templates, training and follow-up checks included in the agreed scope.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
Start a conversation