GLP for biotech startups

You're virtual — no lab, no QA department, and an IND-enabling tox study due next year. Here's how small biotechs handle GLP without building a program they can't staff.

Step 1: outsource the studies

Nearly every virtual biotech runs GLP studies at a contract lab. Your job isn't GLP compliance of a facility — it's sponsor oversight: picking a qualified CRO, auditing it, and reviewing the study. One well-run vendor audit per CRO per year is the baseline.

Step 2: rent the QA function

You still need QA eyes on protocols and reports. Options: a part-time QA consultant, a contracted QA professional, or a GLP consulting firm on retainer for study oversight. Several firms in our directory — including solo practices like Robin Guy Consulting — fit this model.

Step 3: know the trigger for building

Consider an in-house GLP program when your pipeline keeps 2+ regulated studies running continuously, when CRO scheduling or tech transfer is throttling you, or when investors want the asset (and data) in-house. Until then, outsourcing plus strong oversight is the capital-efficient path.

Budgeting on a startup budget

Plan for: CRO study costs (dominant), vendor-audit days (a few thousand to low tens of thousands per audit using published GxP day-rate benchmarks), and contracted QA oversight. The cost guide has sourced figures; the readiness quiz is aimed at labs, but the vendor-audit checklist in our audit guide works for CRO oversight too.