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Building a Virtual Biotech? Here’s How to Stay on Track Without a Full Internal Team

Building a Virtual Biotech? Here’s How to Stay on Track Without a Full Internal Team
Case Study

Building a Virtual Biotech? Here’s How to Stay on Track Without a Full Internal Team

Launching a virtual biotech is faster, leaner, and more capital-efficient than ever before. It’s no surprise that some of the most innovative new therapies are coming from companies with five employees—or fewer.

But running a virtual biotech also means flying without a net. No in-house CMC team. No regulatory department. No program managers watching timelines day to day.

So how do these companies stay on track from candidate nomination to IND—or from tox studies to clinical material release?

At DavosPharma, we’ve supported hundreds of lean teams navigating this exact challenge. And we’ve learned that success doesn’t come from doing everything yourself. It comes from knowing what to outsource—and who you can trust to own it with you.

The Hidden Risks of Running Lean

Being virtual is powerful, but it comes with some structural blind spots. We've seen even well-funded teams stumble because:

  • No one was tracking CMC interdependencies between drug substance, product, and tox
  • Consultants worked in silos, and decisions lacked cross-functional oversight
  • Vendor accountability was unclear, especially when things went wrong
  • Timelines slipped silently, and no one realized until a tox slot or clinical start was at risk

Most virtual teams don’t have the bandwidth to micromanage CDMOs, review raw batch records, or anticipate regulatory concerns in every workstream. And that’s okay—if you have the right partner.

How DavosPharma Keeps Virtual Biotechs on Track

We serve as more than a sourcing agent. We act as your CMC program lead, quality gatekeeper, and problem-solver, helping you run like a 50-person company while staying lean.

Here’s how we help virtual biotechs win:

Integrated Program Management

We coordinate your API, DP, tox, and stability vendors—so you don’t have to. Timelines stay aligned. Deliverables arrive on time. And when changes happen (and they always do), we adjust without disrupting your path to IND.

 Strategic Vendor Selection

You don’t have time to vet 20 CDMOs. We’ve already done it. Our partner network includes proven providers in the US, EU, India, and China—and we’ve worked with many of them for decades. That means you get priority attention, faster response, and fewer surprises.

 Risk-Shifting Contracts

When you contract through DavosPharma, we take on vendor risk. If something breaks, we fix it. That’s a safety net most virtual biotechs don’t even realize they need—until it’s too late.

Regulatory Alignment

We don’t just manage vendors. We ensure your data packages, specifications, and protocols are IND-ready. No gaps. No backfilling. Just a clean submission with no FDA holds.

Real-World Example: From Concept to IND in 15 Months

One of our clients—a 3-person oncology startup—came to us with a lead molecule and a grant. No CMC development experience. No timeline. No plan.

DavosPharma:

  • Built the development roadmap
  • Selected and managed vendors
  • Oversaw API synthesis, formulation, tox, and regulatory
  • Coordinated the pre-IND meeting
  • Delivered a complete IND package ready for submission

They’re now dosing patients in a Phase 1 trial. And they never hired a full-time CMC lead.

Virtual Doesn’t Mean Vulnerable

You don’t need a 10-person internal team to run a world-class development program.
You just need a partner who’s done it before—and who treats your asset like their own.

At DavosPharma, we’ve helped virtual biotechs bring over 80 molecules to IND, with zero regulatory holds and a reputation for getting it done right the first time.

Let’s talk about your molecule, your gaps, and how we can fill them—quietly, reliably, and expertly.

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