We navigate complex Life Sciences regulations to ensure rapid market entry, compliance to the Good Practices and patient safety in North America and in Europe.
Quality, Regulatory, Drug Safety and Human Resources services on both sides of the Atlantic
Permanent and temporary GxP staff on both sides of the Atlantic, plus team training, coaching and expert answers from our QA Clinic.
Explore Staffing & Recruitment ➔We design, audit and remediate Quality Management Systems, and prepare you for FDA, EMA, MHRA and Swissmedic inspections.
Explore our Quality services ➔EU QPPVs and local safety officers (LPPVs/LSOs) in 11 countries, PV system set-up and PVQA audits.
Explore Pharmacovigilance ➔Regulatory strategy and filings for the EMA and FDA: CTAs, INDs/IMPDs, MAAs, NDAs and BLAs.
Explore Regulatory Affairs ➔Proven on both sides of the Atlantic
Scoped engagements for a specific need (e.g. an audit, the preparation of a regulatory filing, the implementation of a quality system, an on-site training, etc.).
Embed vetted consultants directly into your team.
Permanent QA, RA and PV hires sourced by our Recruiter.
Responses to confidential regulatory questions.
What is the first step for a US-based Biotech to launch a clinical trial in the EU?
If you manufacture your Drug Product outside of the European Union, you have to provide the European Health Authorities with a Qualified Person’s (QP) Declaration, issued by the Qualified Person of your European importer (MIAH). This declaration signifies that your manufacturing site has been audited and complies with the principles and guidelines of the European good manufacturing practice. The QP declaration is to be provided with your Clinical Trial Application. Therefore, compliance to EU GMP is something to think about early in the process. With our team of QPs, we can support you along the way.
When does an in-house QA department stop making sense?
Whether to hire or contract QA capacity depends on continuity, peak load and the specific expertise you need only occasionally. A decision framework.
Read her article ➔How is a consultancy model different from staff augmentation?
Staff augmentation places a person. A consultancy model places a person backed by a team, which changes what happens when the problem exceeds one specialism.
Read her article ➔Why does GxP training so often fail?
Read-and-understand training produces signatures, not competence. Effectiveness measurement asks whether behaviour changed, not whether the module was completed.
Read her article ➔What is your vision for Farbridge?
“To be the leading global partner for Quality Assurance consulting, supporting industry standards and best practices, as well as promoting compliance and continuous improvement to our partners.”
What qualifies you to advise us?
I’m an industrial pharmacist (MPharm), a European Qualified Person (QP) and a QPPV, with more than 15 years of experience on both sides of the Atlantic. I founded Farbridge in 2017.
What drives the way Farbridge works?
“At Farbridge, we are unwavering in our dedication to continuous improvement. We believe in applying the principles of continuous improvement not only to our Clients’ systems but also to ourselves as consultants.”
Can I ask you something specific?
MPharm, QP, QPPV — Founder & CEO
“I have worked with Farbridge since 2021 for Quality Systems and QP Audits. Stephanie Verbrugghe from Farbridge, has been an excellent resource and has provided us with exceptional services. She is intelligent, hardworking, knowledgeable in the areas of Quality and GXP Compliance, and strives to do the very best to meet her client’s needs and expectations. I have enjoyed working with Stephanie, and I wish her the very best in all her future endeavors.”
“Farbridge Pharma has led the building and implementation of our GMP quality management system. Stephanie was rigorous, respected her commitments and built compliant processes taking our needs into account. Her capacity of adaptation in our specific and innovative field demonstrated the expertise and the strength of the Stephanie's background.”
“In order to start our clinical trial in Europe, Farbridge Pharma Consulting did a gap analysis of our quality management system and facilities with regards to the European GMPs. We received the results promptly together with informative guidance and advice for us to move forward.”
“Stephanie has been a member of my team for several years as our Qualified Person and QA Manager. She participated actively in early phases of the company among set up and consolidation of quality management system. She was involved in many projects and product releases. She is a competent team player, passionate and dedicated to her assignments and customers.”
“Farbridge Pharma worked together with ABF to ensure compliance of a US manufacturer to EU – GMP regulations. Stephanie has complete knowledge about Quality Management processes for healthcare products, including but not limited to the regulatory framework of current GMP/GDP for human investigational medicinal products and ATMPs, as well as ICH Guidelines on pharmaceutical quality system and quality risk management. With her attention to detail and fast and efficient turnaround times, she was a pleasure to work with.”
“We worked with Farbridge to build our Quality Management System. Stephanie designed the system according to our needs and leveraged her extensive auditing experience to draft and review our procedures. The collaboration with our team went smoothly. Her support was essential for the rapid and successful implementation of the QMS within our company.”
“Farbridge performs audits on our behalf in the USA. Stephanie’s background, reliability and attention to detail make her a great asset to our team. It is a pleasure to work with her.”
“We have had the pleasure to be working with Farbridge and several of its highly competent and dedicated consultants for more than 3 years. The Farbridge team has supported us in the building of our quality system, in our day-to-day QA operations and in our audit activities, ensuring compliance to Australian, American, and European GMPs. Farbridge has been a reliable partner and a pleasure to work with.”
“We hired Farbridge to build our GMP/GCP Quality Management System. The Farbridge team listened to our needs and worked to refine the objectives of the project. They communicated well and reacted to changing priorities while keeping our compliance goals on track.”