How PBM Capital Adds Value to Early-Stage Biotech Companies with a Repeatable QMS Strategy

The Scalable QMS Playbook that Helps Portfolio Companies Hit Milestones Faster

PBM Capital needed a compliant quality management system (QMS) that could be quickly implemented and replicated across its portfolio of early-stage biotech companies. The firm witnessed firsthand the positive experience some of its portfolio companies had deploying and using ZenQMS. It was clear that ZenQMS provided a simple, scalable, and compliant solution that supported its nimble teams with centralized access for remote quality oversight, enabled fast onboarding, and met growing FDA expectations. 

 

The Challenge: Balancing Agility & Compliance Across a Diverse Biotech Portfolio

For PBM Capital’s portfolio companies, lean and nimble is the name of the game. These innovative biotech organizations must move quickly, developing products and advancing through clinical studies while still meeting stringent regulatory requirements. 

PBM supports companies across a broad range of clinical stages, from early preclinical programs to those preparing for commercialization. That diversity created a tall order: they needed an eQMS that was both nimble enough to support the foundational quality efforts of preclinical teams and robust enough to satisfy the complex documentation and compliance demands of Phase III studies and beyond. 

Above all, the eQMS implementation process needed to be repeatable. With multiple companies to support, PBM couldn’t afford a time-intensive, complex rollout process for each organization. The solution had to be fast to deploy, intuitive to learn, and easy to scale, regardless of the company's stage. 

PBM needed a QMS for biotech startups that could:

• Be deployed quickly, with minimal training
• Work across multiple companies, each with different needs
• Scale from preclinical through commercialization
• Meet FDA and global regulatory standards
• Operate with minimal IT resources

“One of our portfolio companies was originally using another QMS platform, and that was driving us crazy. Every time you tried to do something, it was like three other levers you had to pull. It was just unbelievable.” - Gary Massengill, Consultant, PBM Capital Group

 

The Solution: A Scalable eQMS Strategy Built on ZenQMS

PBM discovered ZenQMS through a successful experience at one of its portfolio companies. The system’s quick implementation, intuitive interface, and easy-to-read dashboards made tracking and reporting on compliance a breeze, helping ZenQMS stand out above the rest. 

“When we bring a new company on board, and we're ready to implement a quality management system, we go to ZenQMS because it’s so straightforward and easy to use.”

It helps that PBM has a templated quality manual that accelerates time to value for new companies.

ZenQMS supports PBM Capital’s lean, hands-on model by: 

• Offering built-in training and intuitive navigation
• Allowing portfolio teams to work independently in siloed instances
• Providing configurability without over-complication 

 

Creating a Repeatable QMS Model Across the Portfolio

To streamline new ZenQMS implementations, PBM built a core set of SOPs, templates, configured workflows, and quality documentation using ZenQMS, creating a foundational configuration that could be quickly replicated. 

“ZenQMS sent us a template, and we loaded our generic SOPs and things we wanted to use. Then we just copy those into the new portfolio company. Once you’ve done it once, it’s pretty easy.”

This approach allows PBM to quickly spin up a compliant QMS instance for each new company they bring in – all they need to do is tailor the system for their development stage, team size, or product focus.

“We actually take, just for simplified reasons, a cut-and-paste approach. We take that same number of SOPs and templates and copy them into the new portfolio company when we’re ready to go.” 

 

The Results: Simplified Compliance That Scales With Growth

1. Success starts with compliance… and thrives with scalability

For most startup biotech and biopharma companies, compliance is the most crucial factor when evaluating and implementing a quality management system. PBM Capital ensures that its companies, regardless of their stage, have the necessary resources.

“One thing, first and foremost, is that it has to be a compliant system—you have to meet the expectations of all regulatory agencies and maintain quality standards.”

ZenQMS makes this easy. The transparent quality onboarding process emphasizes access to the tools to quickly qualify, validate, and onboard the company, and maintain a state of compliance. Key to this is a robust set of stand-alone certifications, including HIPAA, ISO 9000, ISO 27001, SOC 2 Type II, and shared third-party GMP audits by USDM Life Sciences. 

“But to me, success is also having a system that can start off small, but grow with us as we’re growing.”

ZenQMS gives PBM Capital the flexibility to start lean and scale as they go without having to switch systems. ZenQMS’s configurability enables PBM Capital to tailor the system to each portfolio company’s specific needs, whether that involves configuring workflow stages, updating category names, or defining document routing and approval processes, all without relying on IT support. It’s a flexible foundation that supports teams from preclinical development and beyond.

“Some of the companies we’ve started with are in very early phases, some are already in Phase III, one has launched a product… and everything is going great.”

 

2. Easy for first-time users

ZenQMS’s training module and UI make onboarding fast and intuitive, even for users new to quality systems. 

For PBM’s portfolio companies, time is a valuable resource. These teams are focused on advancing new therapies, not figuring out how to work complicated software. The last thing they want is to spend hours trying to navigate a new system. With ZenQMS, even new users can get up and running quickly and confidently. 

“The way the training modules are set up is exactly the way the system works… We never have a lot of questions. It’s like, ‘OK, I understand. I can use that now.’”

 

3. Ready for exit

Because PBM eventually steps aside when a company is acquired or goes public, they prioritize systems that can demonstrate value for portfolio companies in a diligence process and/or support them through commercialization. As PBM found in assessing the company, ZenQMS has a 16-year history of supporting clients doing exactly this. 

“We’re building the platform so when a company gets acquired or goes public, everything is in place. FDA correspondence, SOPs – it’s all in there.”

PBM Capital's investment in a compliant quality management system like ZenQMS is a way to protect future revenues, de-risk the entire portfolio, and do so with efficient, repeatable template accounts.

 

Why ZenQMS?

For PBM Capital, the key benefits of ZenQMS include:

• Compliance without complexity: “You have to be compliant with all the regulatory agencies… but also have a system that’s not tedious.”

• Configurable, repeatable onboarding: “Once you’ve done it once, it’s pretty easy.”

• Lean operations support: “We’re only dealing with a few people running a huge program.”

The configurability of ZenQMS has enabled PBM Capital to standardize its approach while providing each company with the flexibility to tailor the system to their specific needs. ZenQMS’ proven ability to scale with clients from preclinical through commercial was a key requirement as well.

If you’re ready to see how these benefits can work for your organization, check out our 3-minute demo video for a quick look at how simple and secure an eQMS can be.