How a Biotech Startup Filed 3 INDs in 1 Year Through Early Quality System Investment
A preclinical biotech company focusing on gene mutation-targeted therapies made an unconventional choice: investing in comprehensive quality systems well before their first IND filing.
Here's the truth about building preclinical quality systems: Building them before you need them isn't just safer—it's faster.
Most preclinical biotechs follow a predictable pattern. They sprint toward their first IND filing with minimal quality infrastructure. Then reality hits: regulatory requirements pile up, documentation gaps emerge, and suddenly they're fighting fires instead of advancing programs. The rushed implementation of quality systems becomes the very bottleneck they hoped to avoid.
In our consulting work with nascent or startup-phase biotechs, we’ve repeatedly found that treating quality systems as a foundation (rather than an afterthought) actually accelerates development timelines.
This case study reveals how one biotech company tested this hypothesis. Instead of the traditional "implement when required" approach, they invested fully in a robust quality infrastructure well before their first IND filing. They brought in a VP of Quality early and partnered with us to embed specialized consultants to build systems that could scale.
The results: three successful IND submissions in a single year—an achievement that often strains even well-established companies. But the real insight isn't just about speed. It's about how early investment in quality created velocity rather than friction.
For growing biotechs racing against time and capital runways, this story invites a question: Could your quality systems be accelerating your progress rather than just ensuring compliance?
The challenge
The company, developing treatments for metastatic and non-metastatic cancers plus a genetic disorder (all linked to mutations in a specific gene pathway), recognized that quality systems would be crucial to their ambitious plans despite their lean team. Their focus on these specific conditions stemmed from their work on mutations that, depending on timing, could lead to either cancer or genetic disorders.
When their VP of Quality joined in 2023, he found:
Disconnected SOPs create a patchwork quality system.
Quality responsibilities scattered across clinical staff.
Multiple uncoordinated quality consultants.
No unified quality vision or strategy.
Immediate need to prepare for multiple IND submissions.
The FDA Group’s approach and solution
Instead of waiting for quality challenges to become critical, the company's general counsel strategically established a dedicated VP of Quality role and partnered with The FDA Group for specialized consulting support. What made this approach unique was its focus on building sustainable systems rather than just addressing immediate needs.
A key differentiator was our emphasis on cultural fit when selecting consultants. Over the course of the engagement, we’ve provided over 20 different consultants, carefully matching technical expertise with the client's organizational culture. In the rare instances where cultural fit wasn't optimal (two cases), we quickly provided alternative consultants who better aligned with the client's needs within days.
Key implementations included:
Technology infrastructure: Our consultant team deployed an integrated suite of compliance technologies, including DocuSign Part 11 for compliant electronic signatures, Box Part 11 for document management, and MasterControl for quality management. Again, each system was implemented with sustainable processes and clear documentation for long-term success.
Quality system development: Rather than creating isolated procedures, our consultants worked hand-in-hand with internal personnel to develop an interconnected quality framework in which each procedure was logically linked to others. This approach emphasized practical, sustainable processes that staff could consistently follow as the company grew. Staff actually wanted to follow these procedures because they had a hand in developing them.
Strategic planning: The team began preparing early for upcoming regulatory requirements, including ICH Q6 Revision 3, positioning the company for future success, whether through independent marketing, technology sales, or acquisition.
Current status and achievements
To date, the team has achieved several significant milestones.
They successfully filed three INDs in 2024 (again, an exceptional achievement for an organization of their size).
Their quality systems are now positioned to support multiple Phase 1 clinical trials beginning in 2025.
The organization has developed a robust quality infrastructure that will support various future scenarios, whether those involve direct commercialization, technology transfer, or acquisition.
Unlike larger pharmaceutical companies, this organization maintained a team uniformly committed to its therapeutic mission. Our consultants adapted their approach accordingly, focusing on creating procedures that were both compliant and practical for daily use. This cultural sensitivity proved crucial in gaining buy-in from stakeholders and ensuring sustainable implementation of quality systems.
A few lessons
The engagement has revealed several valuable insights that inform our continuing practice:
The importance of stakeholder engagement in procedure development cannot be overstated. As the client's VP of Quality noted, even technically perfect SOPs will fail if they don't align with operational realities. Our consultants succeeded by engaging end users in procedure development, creating systems that could become "second nature" rather than burdensome requirements.
The value of maintaining long-term relationships extends beyond active engagements. Our practice of maintaining regular contact with clients, even during periods without active projects (what we call “white space”), helps ensure continuity of support and enables rapid response when new needs arise.
Quick responsiveness to client feedback regarding consultant fit proved crucial to maintaining project momentum and client trust. Our ability to quickly provide alternative consultants when needed distinguished our services from those of other consulting firms the client had previously engaged.
The movement of experienced Quality professionals into the consulting pool isn't just creating challenges; it's also providing companies with new options for maintaining Quality operations in a way that’s often cheaper, faster, and more agile than traditional hiring. Talk to us when you’re ready to start embracing this modern workforce model.
Who is The FDA Group?
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.
With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more.