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SERVICE · REGULATORY COMPLIANCE

Audit-ready, the first time the auditor walks in.

Risk assessments, gap analyses, and SOP drafting for labs working under GMP, ISO 17025, and FDA frameworks. Our consultants have sat on both sides of the audit table.

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GMP · ISO 17025 · FDA
5+ industries covered
On-site gap audits
LDY consultant reviewing GMP documentation with a quality manager
WHAT'S INCLUDED

Compliance work that actually closes findings

Gap analysis

Walk-through of your current SOPs, equipment, and records against the target framework.

SOP drafting

Equipment SOPs and calibration procedures written or revised to meet the framework's intent.

Risk assessment

Process-specific risk register with mitigations, owners, and review cadence.

Audit support

On-site presence during regulatory or internal audits we answer the equipment questions directly.

HOW IT WORKS

Three steps to compliance

1

Scope

Define the framework, the in-scope processes, and the timeline.

2

Analyze

On-site walk-through, document review, and gap register.

3

Deliver

Revised SOPs, risk assessment, and a corrective-action plan signed off by your QA lead.

GETTING AUDITED?

Talk to an LDY compliance consultant.

Tell us the framework and the deadline. We'll scope a remediation plan that lands you ready in time.

Quote Regulatory Compliance

Tell us a bit about your lab and we'll come back with a scope and a price.