Emergency response

When a regulator stops you, the clock starts.

For laboratories and manufacturers alike. ISO/IEC 17025 accreditation suspensions, proficiency-testing failures, and lab data-integrity investigations. FDA Form 483s and Warning Letters. State license suspensions, stop orders, recalls, and seizures. When an authority has halted your lab or your plant, you need senior scientists authoring the response and building the remediation — today, and alongside your counsel.

Get senior help nowSee the situations we handle

A cofounder replies directly — same or next business day, and same-day when a response deadline is already running.

The clock is already running

An accreditation suspension shuts a lab out of its market the day it lands. A Form 483 carries roughly a 15-business-day response window; a Warning Letter, the same. A stop order or a suspended license costs revenue every day it stands. We scope and staff an emergency within 24–48 hours of your call — rapid triage first, then a scoped remediation you approve before the deeper work begins.

How we respond

An enforcement emergency is the worst time to get a junior team and a templated response. Here is how we work one.

“Senior scientists on the call today — not after the sale.”

The people who win the engagement are the people who do the remediation. In an emergency that is not a nicety; it is the difference between a response that lands and one that escalates.

“We author the response and build the remediation. The authority decides.”

Readiness, not grant. We will not promise an outcome we don't control. We will give you the strongest, most defensible response and remediation the facts support.

“We work alongside your counsel.”

We are scientists and quality professionals, not attorneys. On enforcement matters we partner with your regulatory or FDA counsel — they own legal strategy; we own the technical and quality remediation.

“Root cause, not cosmetics.”

A response that addresses only the finding, not the systemic cause behind it, invites the next escalation. We close the system, which is also what the regulator or assessor is actually looking for.

“Phased and decision-gated, even under pressure.”

Rapid triage first, then a scoped remediation you approve. You are not signing a blank check in the middle of a crisis.

“Commitments you can actually keep.”

Every corrective-action commitment carries a date and an owner. We won't write promises you can't execute, because the agency or the accreditation body tracks every one.

What we handle

Two tracks. Every emergency a lab or a manufacturer can face.

The practice is led by Kate Evans, PhD — ISO/IEC 17025 lead assessor, pharmaceutical analysis and cGMP, and FDA test-method submission experience — with the right cofounder on every domain. Prices are starting floors; an emergency is scoped after a rapid triage call, never before.

Track 1

Laboratory emergencies

When a lab's accreditation, license, or credibility is on the line — and with it, the right to report results. Led from the assessor's side of the table.

Accreditation Suspension, PT Failure & Adverse Assessment (ISO/IEC 17025)

When an accreditation body (PJLA, ANAB, A2LA, IAS) suspends or threatens to withdraw a lab's ISO/IEC 17025 accreditation — or a proficiency-testing failure, a major assessment nonconformity, or a threatened scope reduction puts it at risk — the lab can lose the right to report results.

Pricing

Recovery engagement

from $15,000

Suspension or PT review through readiness for the AB's return. Remote-first; on-site if the findings require it.

What we deliver

  • ·Rapid review of the suspension notice, adverse assessment findings, nonconformities, or PT failures behind the action
  • ·Root-cause analysis for each nonconformity or PT outlier — what the assessor will require closed, not just acknowledged
  • ·Corrective-action plan and evidence package the accreditation body will accept
  • ·Method, measurement-uncertainty, or QMS remediation as the findings demand
  • ·Scope-of-accreditation defense where a reduction or removal is threatened
  • ·Mock re-assessment and readiness check before the AB returns

Who leads

Kate Evans, PhD (ANAB and A2LA lead assessor — assessor-side perspective is the differentiator), with Julie Kowalski, PhD (also an ANAB and A2LA ISO 17025 assessor; method validation) and Tess Eidem, PhD (microbiology methods) by domain.

“We've sat in the assessor's chair. We know exactly what closes a nonconformity and what just delays the next one.”

State Testing-Lab License Suspension or Decertification

When a state program suspends or decertifies a licensed testing lab — cannabis, environmental, food, or clinical — the lab is shut out of its market until reinstated. State programs lean on ISO/IEC 17025 plus their own rules; we remediate against exactly what the state requires to restore the license.

Pricing

Reinstatement engagement

from $15,000

Notice review through reinstatement documentation. Scales with the deficiencies cited and the number of methods affected.

What we deliver

  • ·Rapid review of the suspension or decertification notice and the specific deficiencies cited
  • ·Remediation mapped to the state program's reinstatement requirements, and the 17025 clauses behind them
  • ·Corrective-action plan, evidence package, and documentation structured for the state's review
  • ·Method, QMS, or analyst-competency remediation as the findings demand
  • ·Liaison-ready summaries for the lab and counsel to communicate with the state program
  • ·An honest read on the realistic timeline to reinstatement

Who leads

Kate Evans, PhD (ISO 17025 lead assessor; ongoing rule-making and technical advisory to state regulatory bodies) leads, with Julie Kowalski, PhD and Tess Eidem, PhD by domain.

“State programs reinstate on their terms, not yours. We remediate to the exact requirement they will check — nothing skipped, nothing wasted.”

Laboratory Data-Integrity Investigation

When a lab faces an allegation or finding of data manipulation — inflated potency, altered or dropped failing results, round-robin or secret-shopper discrepancies, or a regulator audit of its data — its credibility and its license are on the line. We investigate the data, establish what happened, and build the controls that restore trust.

Pricing

Investigation engagement

from $15,000

Independent data review through remediation and an evidence package. Scope set after a rapid triage.

What we deliver

  • ·Independent review of the data, audit trails, and the analyses in question
  • ·Determination of scope — what is and isn't affected, and the technical root cause
  • ·ALCOA+ data-integrity remediation: controls, audit-trail review procedures, and QMS changes
  • ·Corrective-action plan and evidence package for the accreditation body or state program
  • ·Method and chromatography-data integrity review where results are challenged
  • ·Documentation structured for regulator, AB, or counsel review

Who leads

Kate Evans, PhD (QMS, assessor-side perspective, FDA data-integrity experience) leads, with Julie Kowalski, PhD (analytical and chromatography-data integrity) on the data. Coordinated with your counsel.

“Data-integrity findings are existential for a lab. We establish the truth of what happened and rebuild the controls that let a regulator trust your numbers again.”

Track 2

Manufacturer & facility emergencies

When an inspection, a regulator, or an enforcement action has put your operation at risk — from a single inspection observation to a consent decree.

FDA Form 483 Observation Response

After an FDA inspection you have roughly 15 business days to respond to the Form 483 in a way that actually lands. We turn the observations into a structured, commitment-based response — root cause, corrective and preventive action, evidence, and realistic timelines — authored alongside your quality team and your counsel.

Pricing

Response engagement

from $10,000

Scoped within 24–48 hours of your call. Authored to the 15-business-day clock.

What we deliver

  • ·Observation-by-observation response addressing each item the investigator cited
  • ·Root-cause analysis for each observation — the systemic cause, not just the example the investigator happened to find
  • ·CAPA plan with specific commitments, owners, and completion dates the agency can hold you to
  • ·Evidence package — the procedures, records, and interim controls that show action has already begun
  • ·Immediate corrections put in place inside the response window
  • ·Review against the 15-business-day clock so the response goes out on time

Who leads

Kate Evans, PhD (pharmaceutical analysis and cGMP; FDA test-method submission experience; cross-domain principal) leads, with Andrew Samann (cGMP, ICH Q7 lead auditor, 483-response experience) and the relevant domain cofounder — Julie or Tess — on technical observations. Coordinated with your counsel.

“A 483 response that only fixes the example the investigator happened to find is how you earn a Warning Letter. We fix the system.”

FDA Warning Letter Remediation

A Warning Letter means your 483 response was found inadequate, or the findings were serious enough to escalate — and now it is public. The response is higher-stakes, the remediation deeper, and the agency is watching execution. We build the written response and the remediation program behind it, with your counsel.

Pricing

Remediation engagement

from $15,000

Written response plus the remediation program behind it. Scope set after rapid triage.

What we deliver

  • ·Comprehensive written response addressing every violation cited, on the agency's timeline
  • ·Independent gap assessment of the quality system the letter implicates — finding what the agency has not cited yet but will
  • ·Remediation master plan with phased commitments, owners, and dates
  • ·Root-cause and systemic-corrective-action narrative across the implicated systems
  • ·Evidence and progress documentation structured for a follow-up inspection
  • ·Coordination with regulatory counsel on tone, scope, and commitments

Who leads

Kate Evans, PhD (FDA, pharmaceutical analysis and cGMP; cross-domain principal) leads, with Andrew Samann (GMP, ICH Q7 lead auditor) and Julie or Tess by domain. Works alongside the client's FDA counsel.

“The letter is public and the agency will verify what you promised. Every commitment we write has a date and an owner — because someone will check.”

Stop Order, Operating-License Suspension & Regulatory Hold

When a state, federal, or national authority halts your operations — a cannabis cultivation or manufacturing license suspension, a DEA registration action, an FDA import detention or embargo, a seizure, or a state stop order — every day costs revenue. We assemble the rapid remediation and the documentation needed to lift the hold and reinstate operations.

Pricing

Reinstatement engagement

from $25,000 + travel

Triage to reinstatement documentation. Scales with the scope of the hold and the number of sites.

What we deliver

  • ·Rapid on-site or remote triage of the findings that triggered the hold
  • ·Remediation plan mapped to exactly what the authority requires to reinstate
  • ·Execution support — procedures, controls, retraining, and the evidence the authority will look for
  • ·Reinstatement documentation package, structured for the authority's review
  • ·Liaison-ready summaries for the client and counsel to communicate with the regulator
  • ·An honest assessment of the realistic timeline to reinstatement

Who leads

Kate Evans, PhD leads (FDA, accreditation, cross-domain principal), with Andrew Samann on manufacturing, GMP, and DEA / Schedule III matters and Tess Eidem, PhD and Julie Kowalski, PhD on technical root cause. Travel billed at cost.

“A hold isn't lifted by a promise — it's lifted by evidence the authority's specific concern is closed. We build exactly that.”

Recall & Market Action Support

When a product has to come off the market — a voluntary recall, a regulator-mandated action, or a market withdrawal, whether triggered by a manufacturing failure or by a testing lab's erroneous results — the execution and the regulator communication have to be right under time pressure. We support classification, root cause, corrective action, and the documentation regulators expect.

Pricing

Support engagement

from $15,000

Classification and root cause through corrective action and effectiveness checks.

What we deliver

  • ·Recall strategy and classification support, including health-hazard-evaluation input
  • ·Root-cause investigation of the failure that triggered the action
  • ·Corrective and preventive action to support reinstatement and prevent recurrence
  • ·Regulator-communication documentation and recall-effectiveness checks
  • ·Coordination with counsel and the client's recall coordinator

Who leads

Kate Evans, PhD leads (cross-domain principal; FDA), with Andrew Samann (manufacturing and quality), Tess Eidem, PhD (microbiology and contamination), and Julie Kowalski, PhD (analytical) by domain.

“The recall is the symptom. We close the failure that caused it, so the corrective action survives the follow-up.”

Failing micro COAs specifically?

Start with a two-hour Emergency Microbiology Remediation Session

If the emergency is a microbial test failure, the fastest first move is a focused two-hour session ($1,000) reviewing your failing certificates of analysis and facility data. It can stand alone or feed any of the engagements above.

See the micro session

When it’s an emergency, call us first

Send a note describing what happened and who issued it. A cofounder replies directly — same or next business day, same-day when a deadline is running — and we scope the response within 24–48 hours.

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