Sec 01 · OverviewManaged AI Agent Operations · Biotechnology
Your biotechnology AI agents,
run like production systems.
Nestack Agent Care operates the AI agents behind your research and lab work, regulatory and commercial operations, and quality and supplier oversight. We watch every run, from lab protocols to regulatory submissions, so an unsupported claim or a broken audit trail is caught before it becomes an integrity or compliance failure.
- Failure modes catalogued
- 117
- Agent playbooks
- 13
- Enterprise critical SLA
- 30 min
- Continuous agent operations
- 24/7
PlaybooksSection 02
Pick your agent
Choose from 13 biotechnology agent playbooks to see what each agent does, where it can fail, and how we keep it reliable, compliant, secure, and production-ready.
Run a recorded search, screen records against the stated criteria and extract outcomes into an evidence table — each line bound to the source and page behind it, for a named reviewer to sign.
Open Research-literature copilots7 failure modes
Draft and revise the methods people run at the bench — to your own template, with hazards, version history and the documents each change touches — for a document owner and QA to approve.
Open Lab-protocol assistants7 failure modes
Place each document where the region's structure puts it, validate the sequence against the criteria in force, and show what the content plan still lacks — your regulatory affairs lead decides what is filed.
Open Regulatory-submission helpers7 failure modes
Follow a sample from receipt to result — custody, location, storage excursions, aliquot parentage, timepoints and turnaround — and hold what will not confirm, for your analyst, QC supervisor and QA to act on.
Open LIMS / sample-tracking agents7 failure modes
Draft study-report sections, protocol text and narratives from the locked dataset and your own templates, with numbers tied to the outputs they came from — the medical writer and the study statistician approve.
Open Medical-writing & CSR-authoring copilots7 failure modes
Assemble the account picture, choose from approved in-date content, draft the call plan and turn notes into records — an event or complaint found in a note is pushed to safety on receipt.
Open Field-rep & pre-call commercial copilots7 failure modes
Prepare material for medical, legal and regulatory review — claims read against the approved label, references checked against what they are cited for, expiry tracked — the reviewers who sign still decide.
Open Promotional-content review (MLR) agents7 failure modes
Keep the disclosure record current: which regime each trial sits under, the clocks that follow, and what the registry record still lacks — then hold it for the named responsible party, who submits.
Open Trial registration & results disclosure agents7 failure modes
Track which projects belong to which review body, build the evidence pack behind a required attestation, and hold it for the named principal investigator — who determines the classification and signs it.
Open Research-oversight & attestation evidence agents7 failure modes
Maintain the site file behind an external-manufacture relationship — what the site is qualified for, its audit cycle, open findings and certificate currency — and hold it for the Qualified Person who signs.
Open Supplier, CMO & quality-agreement agents7 failure modes
Carry the promises made to a regulator on one register — milestone, status word, market, the evidence behind a change — then hold it for the named regulatory lead, who decides what is filed.
Open Post-approval change & commitment agents7 failure modes
Track each protocol, amendment and semiannual review against the interval it is measured by, and put the calendar, the findings and their correction dates in front of the committee that signs.
Open Animal care & use protocol governance agents7 failure modes
Pull the review period's batch, deviation, out-of-specification, change, complaint, return and stability inputs into one pack, reconciled to the registers they came from — the conclusion stays with the heads who sign.
Open Product quality review assembly agents7 failure modes
Regulatory map
The rules your biotechnology agents answer to
Every failure mode in the Biotechnology playbook is mapped to the rule it could breach. These are the 16 regulatory areas we watch, each with its citation.
- 01Adverse-event intake & expedited clocks21 CFR 312.32(c)(1)(i) · 21 CFR 312.64(b) · 21 CFR 314.80(b)4 failure modes
- 02GMP batch records, release & sample custody21 CFR 211.188(b) · 21 CFR 211.194(a) · 21 CFR 210.1(b)6 failure modes
- 03Consent, IRB oversight & participant data21 CFR 50.27(a) · 21 CFR 56.109(a) · 45 CFR 46.111(a)(7)4 failure modes
- 04Electronic records, audit trails & validation21 CFR 11.10(a) · 21 CFR 11.10(e) · 21 CFR 11.10(k)(2)7 failure modes
- 05Out-of-specification, QC & stability21 CFR 211.192 · FDA out-of-specification guidance (Revision 1, May 2022) · ICH Q1A(R2)5 failure modes
- 06Submission assembly & eCTD lifecycle21 CFR 314.50 · 21 CFR 314.60(b) · FDA eCTD v4.0 Technical Conformance Guide v1.58 failure modes
Sec 03 · Procedures
Onboard → Observe → Respond → Improve → Verify
We instrument your agents, watch them around the clock, turn incidents into fixes, verify that improvements hold, and deliver a monthly audit-ready scorecard your board or regulator can read.
When an agent misbehaves, nobody improvises — the crew flies the procedure.
Agent incident response
Applies: SEV-1 / SEV-2 / SEV-3
DetectEP-1
An alert, failed evaluation, guardrail event or human reviewer identifies a risky session. The case is acknowledged according to the applicable response target.
ContainEP-2Memory item
For a SEV-1 incident, pause the affected workflow, restrict the risky tool or move the agent into an agreed safe mode before full diagnosis. Containment authority is established during onboarding.
DiagnoseEP-3
Correlate the goal, retrieval, plan, workflow, task, tool, LLM, evaluation and guardrail records; identify the affected slice, classify the failure mode, and locate the earliest critical decision that caused the issue.
RemediateEP-4
Apply the relevant runbook and correct the affected prompt, workflow, tool configuration, data source or guardrail. Link the change to the originating evidence and verify the affected slice through targeted output, step or trajectory evaluations before restoring autonomy.
NotifyEP-5
Notify the client according to the agreed communication target. SEV-1 updates include affected agents, impacted sessions, containment status, probable source and next action.
LearnEP-6
Complete the post-incident review within five business days. Close the incident only after the failure mode, corrective action and verification evidence are recorded, and the relevant evaluation case, guardrail or runbook has been updated.
Nestack Agent Care contains the immediate risk, identifies the failed operational layer, verifies the corrective action, and converts the incident into reusable evidence for future monitoring and evaluation.
AI Agent Care pricing, made simple
Per agent. Per month. Pay only for the AI agents actively running in production.
Agent Care
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