CROs. CMOs. Distributors & Sales Intermediaries.

Life sciences companies operate through some of the most complex third-party ecosystems in any industry. CROs. CMOs. Distributors. Healthcare providers. Sales intermediaries. Lab suppliers. Each relationship carries regulatory weight — and the agencies watching don’t accept “we didn’t know” as an answer.

FDA audits, GMP violations, ABAC enforcement actions, clinical trial failures — the consequences of a third-party risk program that can’t keep pace aren’t measured in fines alone. They’re measured in delayed drug approvals, consent decrees, and reputations built over decades that unravel in a single enforcement cycle.

Most life sciences compliance teams are managing this across a patchwork of spreadsheets, manual DDQs, and point solutions that were built before AI existed. Periodic assessments leave blind spots that continuous regulators won’t forgive. Supplier onboarding bottlenecks slow clinical timelines. And when the FDA asks for an auditable book of record, pulling it together takes weeks it shouldn’t.

Certa gives life sciences companies the infrastructure to know their third parties are compliant, respond before regulators identify the gap, and prove it with documentation that’s built automatically — not assembled in a panic.