Here is a sobering fact: between 2018 and 2023, the FDA issued more than 260 warning letters, recalling over 700 products between 2012 and 2021 alone, all due to issues linked to stability studies.

Every day your product is delayed, your path to market slows. Stability studies are a regulatory requirement, but with guidelines difficult to interpret or implement for many manufacturers, as well as expensive protocols and costly delays at stake, they can quickly become a source of frustration and risk, particularly for patients.

Whether you're launching a new drug or managing lifecycle support, ensuring the long-term safety, efficacy, and quality of your product is non-negotiable.

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides expert support across the entire lifecycle of your stability programme – from method development to analysis, storage, and reporting – helping you meet international regulatory standards including ICH Q1(A), ICH Q5C, and VICH GL3.

Our GMP-compliant facilities offer:

• An unequalled storage capacity
• In-depth knowledge of regulatory requirements
• Extensive experience in designing stability studies
• State-of-the-art equipment in our analytical laboratories
• Proven expertise in interpreting trends

With secure, monitored climatic chambers, your samples remain safe at all times, with sample storage for both short- and long-term needs.

Our expert teams will work with you to optimise your study design, helping to reduce costs while ensuring compliance. If your study was conducted in-house, we can assist in interpreting results or continuing analysis using the same protocols.

Whether you’re conducting early-phase studies or preparing for submission, we ensure a seamless experience with rapid setup and data access. Our tailored services help you stay agile, avoid regulatory pitfalls, and focus on what matters—getting your product to patients safely and efficiently.

Our clients trust Eurofins BPT to deliver stability studies that remove uncertainty and help them make the right decisions faster.

Reliable data. Controlled environments. Complete confidence.

Our stability programs evaluate the physical, chemical, and microbiological properties of your product to ensure it meets specifications throughout its shelf life. Whether you are developing a new product or supporting an existing one, we generate the data required to establish or confirm expiry dating for both active pharmaceutical ingredients (APIs) and finished products.

Secure infrastructure built for consistency and compliance

All stability chambers are housed within secure, controlled environments with:

• Continuous 24/7 temperature and humidity monitoring
• Redundant systems and backup power to protect study integrity
• Fully validated, computerised LIMS systems for data management
• Real-time visibility through secure client access portals

Conditions for other climatic zones, custom conditions and photostability also available!

This infrastructure ensures your studies remain compliant, traceable, and audit-ready at every stage.

Designed around your study and regulatory requirements 

We develop and execute stability programs aligned with ICH Q1 guidelines, ensuring global regulatory acceptance.

Our services:

• Stability protocol design and program setup
• Sample storage and scheduled testing
• Method development, validation, and transfer
• Execution of client-supplied methods and specifications
• Freeze–thaw studies to assess temperature excursion impact
• Interim reporting at each study interval
• Final reports with complete data evaluation

A stability partner that keeps you moving forward 

You need more than storage capacity—you need a partner who understands timelines, regulatory expectations, and the importance of consistent, high-quality data. Our experienced teams work closely with you to:

• Design efficient, compliant stability programs
• Minimise risk of data gaps or study disruptions
• Support global regulatory submissions with defensible results
• Deliver timely reporting to keep your milestones on track

Get in touch

With proven expertise and scalable capacity, our Toronto experts partner with you to accelerate development, maintain compliance, and bring products to market with confidence.

Contact us