Cart
Account
Your Orders
Sign In
What is a GMP Open House?
The GMP Open House is an informal, collaborative visit where we open our doors to share how we operate. It’s not an audit or a formal due diligence process—it’s a behind-the-scenes look at our quality infrastructure and how we comply with GMP standards.
During your visit, you’ll meet with key members of our quality team, including leads from MSAT, QC, QA, and Regulatory Affairs. We’ll walk you through our systems and processes, provide a high-level overview of our capabilities, and even give you a guided tour of our manufacturing facility. It’s a focused, 90-minute session, fitting into your busy schedule while giving you valuable insights into how we can support your clinical program.
The GMP Open House is a pre-audit overview designed to help you evaluate whether Synthego is the right partner for your program-before investing in a formal audit process.
What makes it different?
- Focused and efficient: 90 minutes vs. multi-day audits
- High-level and strategic: overview of systems and capabilities, not detailed compliance verification
- Collaborative and transparent: meet out quality leadership and ask the questions that matter most to you
- Convenient and cost-efficient: minimal preparation required from your team
What to Expect During Your Visit
The Quality Open House is designed to be a streamlined and informative experience. Here’s what you can look forward to:
Quality Systems Overview
Get a high-level understanding of how we manage critical quality processes—from non-conformance tracking and CAPA to change control, training, and environmental monitoring. You'll see the systems and tools we use to ensure compliance and continuous improvement.
Commercial Readiness Discussion
Review our quality metrics, regulatory inspection history, and supplier qualification program. We'll share data that demonstrates our track record and readiness to support commercial-scale programs.
A Guided Facilities Walkthrough
Tour our GMP manufacturing suites, quality control labs, and material storage areas. See firsthand the environment where your product would be manufactured and the controls we have in place.
Direct Access to Our Leadership
Meet and ask questions of our quality leadership team, including heads of QA, MSAT, QC, and Regulatory Affairs. This is your chance to assess not just our systems, but the people who will support your program.
Why It Matters For You
When you’re working on a GMP project, every detail matters. Selecting the right CDMO is critical to your program's success. The GMP Open House helps you make that decision with confidence by giving you direct visibility into our quality infrastructure and team.
Benefit: Make Informed Decisions Faster
Supplier selection can take months when teams lack confidence in their evaluation. The GMP Open House gives your decision-makers direct access to our systems and leadership, helping you move forward with clarity.
Benefit: Reduce Risk Early
See our quality infrastructure in action before committing to a partnership. You'll have the information you need to assess whether we're the right fit—before you're deep into tech transfer.
Benefit: Build a Strong Foundation
If you choose to move forward with Synthego, you'll enter the partnership with a clear understanding of our capabilities and a relationship with our quality team already established.
Benefit: Evaluate with Confidence
Whether you're comparing multiple CDMOs or conducting final due diligence, the GMP Open House gives you consistent, transparent information to support your decision.
This isn’t just about learning what we do; it’s about building confidence in how we do it. By seeing our quality infrastructure in action, you’ll leave with a deeper understanding of how we can help you achieve your clinical and commercial milestones.
What Happens After?
The GMP Open House is designed to help you determine the right next step for your program. After your visit, we'll work with you to:
- Answer any follow-up questions that arise from your visit
- Provide additional documentation if needed to support your evaluation
- Discuss next steps based on your timeline and requirements
Whether that means moving forward with a formal audit, scheduling additional discussions, or staying in touch for future opportunities, we're committed to supporting your decision-making process.
Let's Connect
We’d love to welcome you to Synthego and show you how we’re setting the standard for GMP compliance in clinical CRISPR manufacturing. Whether you’re preparing for an IND, scaling for late-phase trials, or gearing up for commercialization, the GMP Open House is your chance to see how we can support your success.
Ready to Schedule Your Visit?
Connect with us today to plan your GMP Open House and take the first step toward a successful partnership.
