Full managed service: software + dedicated team + FDA expertise.
Stop building what you can outsource.
The Problem
Most biotech companies between Series A and Series C cannot afford a full compliance team. Yet FDA expects the same rigor from a 50-person startup as from Pfizer.
And that is just salary. Add recruiting costs ($50K-$100K per hire), benefits (25-35% overhead), onboarding time (3-6 months to productivity), and the risk of key person departure.
The alternative? Consultants at $300-$500/hour who leave no institutional knowledge behind. Or doing nothing and hoping FDA does not notice.
Our Model
For a fraction of the cost of building in-house, we provide the Nessa platform plus a dedicated team of compliance professionals embedded in your organization. They know your systems, your data, and your regulatory strategy.
Your dedicated team operates as an extension of your organization. They attend your standups, know your pipeline, and maintain your validation documentation. When FDA calls, they are ready.
Unlike consultants, our teams build institutional knowledge that stays with your account. Unlike in-house hires, you get immediate expertise with no recruiting risk and no ramp-up time.
We handle everything: system validation, audit trail management, SOP authoring, CAPA processes, deviation investigations, annual product reviews, and FDA inspection preparation.
What's Included
Pricing
All tiers include the Nessa platform license. Scale your team as your pipeline grows.
Ideal For
Let us handle your compliance so you can focus on developing therapies that save lives. Schedule a call to discuss which tier fits your pipeline.
Talk to Our Team