Policy & SOP Development

Ensure Ethical, Compliant & Scalable Operations in Pharma & MedTech

Build governance frameworks, automate compliance, and train your teams — all under one trusted partner.

SOP Development Services

Why It Matters

In today’s tightly regulated healthcare landscape, failing to maintain robust compliance programs exposes pharma and medical device companies to:

  • Regulatory penalties and investigations
  • Damage to brand integrity and patient trust
  • Internal inefficiencies and inconsistent processes
  • Resource-heavy complaint management

Our Solution

We help organisations design and implement effective compliance programs with:

  • Governance framework design (global & country-specific e.g., UK, ROI)
  • Monitoring, risk, and maturity assessments
  • Complaint management and PMCPA/regulatory defense
  • SOP and compliance automation using SharePoint, Power Apps, Veeva, and Salesforce

FAQs

Why are policies and SOPs important in healthcare compliance?

Policies and SOPs provide the operational backbone of a compliant organization. They establish clear rules, assign responsibilities, reduce ambiguity, and ensure regulatory expectations are met across business activities—from HCP engagements to promotional practices.
We support the creation of both global and local policies and SOPs covering a range of topics, such as HCP/HCO interactions, FMV, transparency reporting, promotional review, third-party due diligence, grants and donations, patient support programs, training, monitoring, and more.
Yes. We specialize in developing harmonized global policies with embedded country-specific annexes, ensuring both consistency and flexibility to address national regulatory differences (e.g., ABPI in the UK, Loi Bertrand in France).
We offer both. You can leverage our robust library of best-practice templates or opt for fully customized SOPs developed in close consultation with your internal stakeholders to reflect your operating model and risk appetite.

We build policies that are adaptable and regularly reviewed. We also offer a policy maintenance service that includes periodic updates based on changes in global codes (like EFPIA, IFPMA) and local laws.

We use a consultative, risk-based approach: starting with stakeholder interviews and gap analysis, followed by iterative drafting, SME validation, and structured reviews—ensuring each SOP is practical, compliant, and easy to operationalize.

Yes. We modernize legacy documentation, consolidate duplications, simplify overly complex SOPs, and align the structure with current regulatory expectations and business needs.

Absolutely. We offer tailored training sessions—both live and virtual—to roll out new or updated policies. These sessions are designed to promote adoption, clarify roles, and address real-world application challenges.

We offer both models. You can engage us for a single project (e.g., an FMV policy) or partner with us on an ongoing basis to maintain a living, breathing compliance document library as your organization grows or expands geographically.

Just reach out via our Contact Page or email hello@eunomiapharmaservices.com. We’ll begin with a short discovery session to understand your documentation landscape and compliance objectives.

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