Why It Matters
- Process errors and inefficiencies
- Employee confusion and retraining costs
- Audit failures and compliance risks
- Low adoption and poor user experience
Our Solution
- A suite of 14 essential SOP & Policy templates
- Help with customization based on your organization’s needs
- Full lifecycle Policy/SOP development support
- Lean Six Sigma-informed improvements to eliminate waste and streamline your processes
FAQs
What is a compliance program, and why does my company need one?
A compliance program is a structured framework that helps organizations operate ethically and within the law. It mitigates risk, promotes accountability, and ensures adherence to healthcare regulations, industry codes, and internal standards—essential for pharmaceutical and life sciences companies operating globally.
What does Eunomia’s compliance program design and implementation service include?
Our service includes designing a fit-for-purpose compliance framework covering risk mapping, policies and SOPs, training programs, monitoring systems, third-party due diligence, reporting channels, and governance models. We tailor everything to your business size, structure, and geographic footprint.
Can Eunomia help us build a compliance program from scratch?
Yes. Whether you’re an early-stage biotech, a medical device start-up, or expanding globally, we can help you build a compliance program from the ground up—ensuring alignment with global regulations like EFPIA, FCPA, UK Bribery Act, and regional industry codes.
What if we already have a compliance program—can you still help?
Absolutely. We assess the maturity of your existing compliance framework, identify gaps, and implement upgrades to make your program more efficient, scalable, and aligned with evolving regulatory expectations.
How do you ensure the program is tailored to our company’s risk profile?
We begin with a compliance risk assessment to identify specific exposure areas based on your operations, therapeutic focus, and geographic presence. This insight informs every aspect of the program design—from policies to training and monitoring mechanisms.
Do you support the development of policies and SOPs as part of the compliance program?
Yes. We develop clear, practical, and code-compliant policies and SOPs that reflect your internal processes while meeting local and global regulatory expectations. We also help socialize them across teams for effective implementation.
Can Eunomia provide tools and templates for compliance documentation?
Yes. We offer a library of customizable templates, toolkits, and best-practice guides to accelerate implementation and ensure documentation consistency across your compliance operations.
How do you approach the implementation phase?
Implementation is managed in phased steps—prioritizing quick wins and critical risk areas first. We engage internal stakeholders, conduct onboarding and training, and embed governance structures, ensuring that compliance becomes part of your operational DNA.
Do you offer support after the program is implemented?
Yes. We offer ongoing compliance support, including monitoring, periodic reviews, refresher training, and updates to policies or procedures as regulations evolve.
How do we get started with building our compliance program through Eunomia?
It starts with a discovery call. Reach out to us via our Contact Page or email us at hello@eunomiapharmaservices.com. We’ll assess your needs and propose a clear roadmap to establish or strengthen your compliance framework.