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Quality As A Service

According to Regulation (EU) CTR 534/2014, in an outsourced model, a sponsor is ultimately responsible, accountable, and liable if something goes wrong. Therefore, it’s vital to set up a sponsor QMS.

2 Bridge has developed a lean ‘early phase’ QMS blueprint, a QMS focused on oversight of GxP vendors, a QMS basic pack tailored to start-ups working in an outsourced GxP model to kickstart GxP compliance for early-stage programs.

For startups, the development of a QMS from scratch is time-consuming and not the priority of your internal team. 2 Bridge has developed a QMS blueprint that can be translated into any start-up setting to expedite Compliance in GxPdevelopment, in a staged approach.

We take away the burden of developing a QMS from the scratch.

Quality Development and Management Solutions

Who do we support

Start-ups ‘pre-internal’ QMS development stage

Start-ups ready to develop internal QMS

How do we support

Management of GxP oversight under 2 Bridge QMS

Phase 1: QMS basic pack
covering oversight on non-GCP GxP activities

Phase 2: QMS extended pack
covering GCP activities oversight

What does it include

GxP compliance in start-up phase without major financial investment

Basic set of approx. 10 procedures/ templates to manage ‘pre-GCP GxP’ activities

Approx. 20 procedures/ templates/ forms to manage ‘GxP’ studies including GCP

Management in fully validated e-QMS (SciLife) possible

Other quality services

Audit management support
Quality event management
Quality agreement management
Risk management
EU QP certification

Geertje Van Beeck

Managing Partner & Head of CMC

An Industrial Pharmacist with over 25 years of experience in CMC and quality management.

A cross-functional team consists of many disciplines.  The quality representative is often not the most favorite team member but he/she is essential for the success of any clinical development. The safety of patients should be at the heart of any Sponsor’s objective. Most of our clients work in an ‘outsourced business model’ and this means that keeping oversight on GxP activities at CROs/CMOs can be a real challenge.

Our cross-functional experts in GMP/GCP/GLP and GDP have developed a lean, flexible, and adaptable phase-appropriate ‘QMS blueprint’ tailored to ensure GxP oversight for Sponsors involved in early clinical phase development. We give our clients the flexibility to implement their QMS in a staged risk-based approach and always ensure to be pragmatic and constructive.

Our quality experts are not there to tell the team what they can or cannot do, but we strive to help teams by introducing structure to a project and we help the team by introducing and guiding them on ‘Good Documentation Practises’ from the onset of a project.

We also give training to academic partners on the meaning of GxP as this is often an ‘unknown’ territory.

The Quality team is key to a successful development program, we are not your enemy!