Good Laboratory Practice (GLP) studies occupy a specific, but often misunderstood and underestimated, space in medical device and pharmaceutical development. Most everyone knows when they're required. Most innovators budget for them. But surprisingly few truly understand what GLP studies are, and more importantly, what they're not.
These misconceptions aren't just academic misunderstandings. They lead to failed studies, regulatory setbacks, wasted budgets, and delayed market entry. After years of managing GLP preclinical studies at Veranex, I've seen the same costly misconceptions repeated across startups and established companies alike. They arrive at my desk as rescue or repeat studies of originals performed elsewhere.
Here are the five most damaging misconceptions about GLP studies, and what you need to know instead.
The Reality: GLP studies are not practice. They're the real deal.
This is perhaps the most dangerous misconception. GLP studies conducted under 21 CFR Part 58 aren't warm-ups for your clinical work. They're regulatory submissions in the making, with their own specific endpoints tied directly to what notified bodies need to approve human trials.
Think of GLP as a high-stakes bridge from product design and engineering to clinical work. It's not a preview; it's a make-or-break moment. We've seen devices that engineering teams were supremely confident in fail during GLP work. Parts break, designs don't function as expected, or we discover safety concerns that prevent human use.
Your GLP study can validate your device's readiness for human testing, or it can send you back to the design phase for significant rework. There's very little middle ground, and there are no second chances within the same study.
The endpoints in GLP work are specific to regulatory requirements, not to mimicking clinical scenarios. While preclinical models get close to human anatomy and physiology, they're controlled environments that can't fully replicate human behavior (neither from patients nor clinical staff) or real-world clinical settings.
Bottom line: If you're treating GLP as exploratory work or a "test run," you fundamentally misunderstand its purpose and are heading towards high dollar, avoidable expenses incurred.
The Reality: GLP work is critical, often underestimated, and absolutely essential to your device's commercial success.
In many organizations, product development engineering and clinical/regulatory teams receive significant, appropriate attention and resources. Preclinical work sometimes gets minimized or relegated to "just another milestone" on the development roadmap.
Here's the truth: Clinical trials don't happen without successful GLP preclinical studies. Your engineering and design work doesn't advance to human testing without GLP. It's not a supporting role. It's a starring one.
You can tell which clients have been through GLP work before because they approach it differently. They plan a year in advance. They budget appropriately. They know this phase will consume significant focus and resources, and they respect the process because they've learned what happens when you don't.
Then there are companies that tell us they've never done animal work, want to start next week, and need results by year-end starting in September. The disconnect reveals their inexperience and sets them up for expensive lessons.
Bottom line: On your device development roadmap, preclinical GLP work requires the same strategic priority as design validation and clinical trials. Minimize it at your peril.
The Reality: GLP studies have hard timelines that cannot be compressed, period.
This misconception costs companies dearly because it's rooted in wishful thinking rather than regulatory and biological reality. Companies call us regularly asking what it would cost to "expedite" their GLP study or compress a 12-month timeline into 8 weeks.
The answer: It can't be done, at any price.
Here's why: Certain processes in GLP work have mandatory timelines. Histopathology processing, particularly plastic resin embedding, requires 8 weeks minimum, and that's if everything proceeds perfectly. Reporting alone takes 12 to 16 weeks for data analysis, documentation, quality review, and finalization.
Realistic GLP timelines run 3 to 6 months from the end of in-life to final signed report. Some processes can be prioritized or expedited slightly, but the core biological and documentation requirements remain fixed.
When you try to rush GLP work, the results show. Quality suffers. Protocol deviations multiply. Regulatory reviewers notice.
Bottom line: Budget realistic timelines. If your CEO announces a December submission deadline in September, you're already too late. Plan backwards from your regulatory goals, not forwards from today.
The Reality: Some things cannot be money whipped. GLP work is one of them.
This misconception overlaps with #3, but it deserves its own section. Large companies with substantial resources will ask what it would cost to "throw more resources" at a GLP study to compress timelines dramatically.
While adequate budget is absolutely essential (underfunding GLP work creates its own set of problems), excess budget doesn't eliminate biological and regulatory constraints. You cannot pay to make tissue process faster than tissue processes. You cannot pay to make data analysis more thorough than thoroughness requires.
What money can do: Ensure you work with a high-quality, compliant and accredited CRO, have proper resources allocated, and don't cut corners that compromise data quality. What money cannot do: Violate the laws of biology and circumvent regulatory requirements.
Some aspects of GLP work can be prioritized in scheduling (moving to the front of the queue for certain resources), but this delivers marginal timeline improvements, not wholesale compression.
Bottom line: Appropriate budget is table stakes. Excess budget isn't a time machine.
The Reality: GLP is not experimental. You're generating regulatory documentation, not discovering new insights.
This might be the subtlest but most consequential misconception. Companies sometimes treat GLP studies as opportunities to "see what happens" or "test a few different approaches" or "gather exploratory data while we're at it."
This is precisely backwards.
By the time you initiate GLP work, you should be out of the experimental phase entirely. Your pilot studies should have already answered the "what if" questions. You should have high confidence in your protocol, your model, your endpoints, and your expected outcomes.
Think of it like a lawyer in court: You never ask a question you don't already know the answer to. Similarly, in GLP work, you're not generating insights. You're generating regulatory-quality documentation of what you've already confirmed works.
GLP studies have specific, pre-defined acceptance criteria. These aren't open-ended research questions; they're targeted regulatory requirements. If your acceptance criteria include safety, you need to know exactly how you'll demonstrate it (histopathology scores, clinical observations, biomarkers) and have confidence those measures will show what you expect.
Adding "bonus" data points or exploratory endpoints to your GLP study isn't value-add. It's risk additive. Every piece of data you generate can raise questions. Every hypothesis you test can produce unexpected results that complicate your regulatory pathway.
Bottom line: Save experimentation for pilot work. GLP is for confirmation and documentation.
These aren't just semantic distinctions or philosophical disagreements about GLP's role. Each misconception leads directly to tangible failures:
The companies that succeed in GLP work understand its true nature. It's a critical regulatory milestone that demands respect, appropriate resources, thorough preparation, and strategic execution.
At Veranex, we've built our reputation on GLP studies that succeed the first time. Our preclinical contract research facilities in Atlanta and Paris have supported more than 200 regulatory submissions, with the vast majority returned with minimal or no questions from regulatory bodies.
What sets us apart:
We don't just conduct GLP studies. We help innovators understand what GLP readiness really means and guide them through pilot work, protocol development, and regulatory strategy. Whether you're a first-time innovator or an established company launching your next device, we ensure you approach GLP work with clarity, not misconceptions.
Ready to discuss your GLP preclinical needs with a partner who gets it right? Contact Veranex today to learn how our integrated approach (combining preclinical excellence, histopathology expertise, and regulatory insight under one roof) can accelerate your device's path to market.
About the author: Michael Sweet is the director of preclinical study management and a study director at Veranex Preclinical Services – Atlanta, bringing 15 years of specialized expertise in GLP-compliant preclinical research. His extensive experience spans ECMO/VAD devices, interventional cardiovascular procedures, and structural heart models, establishing him as a leading authority in complex medical device evaluation. As a biomedical engineer and researcher, Michael integrates deep technical knowledge with hands-on expertise across multiple imaging modalities, including ultrasound, micro-CT, MRI, and CT. His proficiency in scientific data analysis, advanced imaging technologies, and cardiovascular study design, combined with his ability to translate complex findings into clear, actionable scientific documentation, makes him an invaluable asset to medical device developers seeking rigorous preclinical validation of their innovations.