Simplify and accelerate GMP compliance

Stay audit-ready and fast-track GMP compliance with targeted risk assessments, industry data and expert SOPs.

What's included?

Qualification
All

Develop and rollout of a best-in-class CCS

Qualification
All

Complete support from Raw material selection, sampling, testing, release and management

Qualification
All

Create an industry-leading Validation Master Plan

Qualification
All

Work with the experts on deviations and root cause analysis

Qualification
All

Accelerate tech transfers by developing a process agnositc qualification approach for your SU materials

Qualification
All

Ensure leak-free connectivity in your process with our welding and sealing expertise

Qualification
All

Ensure your product is free of unwanted contaminants from your SU materials

Qualification
All

SCNs are impact assessed quickly and managed appropriately.

Qualification
All

Ensure the information in your SU library is working for you, not the other way around.

Qualification
All

Ensure your qualified status is maintained through inevitable changes

Qualification
All

Conduct internal audits to ensure continuous compliance.

Qualification
All

Stay ahead of regulations with thorough GMP risk assessment and mitigation.

Qualification
All

Bring your E&L qualification program up to date with current regulatory expectations.

Qualification
All

Ensure all your materials are integral and leak free prior to use.

Ensure compliance

Our qualification framework safeguards every stage with precision and efficiency.
Risk-Based URS
Develop a URS tailored to your project's unique requirements and compliance standards.
Regulatory Readiness
Stay ahead of evolving GMP regulations through comprehensive risk assessment and mitigation.
Critical Focus
Prioritize and manage critical risks to optimize both time and resources.
SOP Integration
Embed best practices into your project with expertly developed and managed SOPs.

Getting started with us

A structured approach that brings clarity and confidence to every stage of your project.
Define scope
Share your project needs, timelines, and objectives so we can align on scope and deliverables.
Use our calculator →
Receive proposal
We’ll provide a fair, competitive proposal based on your project's requirements, timelines, and resources.
Kick off work
Once the purchase order is received, our team gets to work, keeping you updated at every stage.
Get to know us →