Life Sciences
Patients depend on continuity. So does the licence to operate.
For business continuity, quality, and operations leaders in pharma, biotech, and medtech — where production disruption affects patients, triggers regulator notification, and demands evidence that the program runs to GxP standards.
One practice for continuity, quality, and the regulators who watch both
Life sciences resilience is not just operations — it's quality, regulatory, supply, IT, and OT, all bound together by patient outcomes and inspector expectations. resimate brings them into one practice: a living view of what production actually depends on, exercises that build response confidence across functions, and continuous evidence ready for the next FDA, EMA, or notified body inspection. One program. Built once. Runs continuously.
The practice
What See / Improve / Prove looks like here
See
Map your critical production assets, validated systems, cold chain, and key suppliers in one place. Understand which disruptions threaten patient supply and where focused investment protects the most.
Improve
Exercise the scenarios that matter — API supplier failure, batch loss, cyber incident on validated systems, notified body finding. Build muscle memory across quality, operations, and BCM together.
Prove
Maintain inspection-ready evidence aligned to GxP, ISO 22301, and NIS2. Show inspectors, customers, and the board a program that runs continuously and stands up to scrutiny.
Compliance coverage
Aligned to the standards life sciences are held to
GxP / GMP
Good Practice and Good Manufacturing Practice obligations for production continuity, validated systems, batch integrity, and documentation across pharma, biotech, and medtech.
FDA & EMA
Drug shortage notification, manufacturing change reporting, and inspection readiness — including 21 CFR Part 11, Annex 11, and post-market surveillance for medtech.
ISO 22301
BCMS certification, BIA methodology, and continuous improvement — increasingly expected by partners, payers, and regulators.
NIS2
Cybersecurity, supply chain, and continuity obligations for pharma and medtech operating in the EU — including incident notification and management accountability.
Who built this
Practitioners who've worked inside pharma and medtech resilience programs
resimate was built by people who've run resilience programs across global pharma and medtech companies — and who understand what an FDA inspector looks for, how quality and BCM need to speak the same language, and what it takes to keep validated systems and supply continuity in one conversation. The product is what we wanted in the role.
See what resimate looks like for your operation.
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