Athyrion provides practical consulting services for small and mid-sized organizations preparing for FDA expectations, customer audits, ISO/IEC 17025 accreditation, ISO 9001 certification, CAP or CLIA requirements, USP-related quality expectations, and broader quality system improvement.
Our Approach
Understand your current quality system, records, risks, and audit exposure.
Identify the most important gaps and focus on the actions that reduce risk fastest.
Develop practical procedures, forms, records, training, and workflows your team can maintain.
Assign ownership, roll out processes, train personnel, and establish evidence of execution.
Support internal audits, certification readiness, accreditation readiness, customer audits, and inspection preparation.
Use findings, metrics, CAPAs, and management review inputs to strengthen the system over time.
What We Offer
Help organizations strengthen quality system structure, documentation, training, audit readiness, and compliance practices for FDA-regulated and GxP environments.
Support laboratories preparing for accreditation or improving laboratory quality controls, including document control, technical records, calibration/equipment controls, internal audits, uncertainty/traceability readiness, and accreditation body preparation.
Practical quality system support for laboratories, blood banks, and regulated testing environments that need organized records, procedures, training, and audit-ready evidence.
Quality manual and procedure development, gap assessments, internal audit support, certification preparation, corrective action support, and quality system maturity improvement.
Review current practices against applicable standards, identify missing controls, prioritize remediation, and create a clear readiness plan.
Write or revise SOPs, policies, forms, templates, process maps, quality manuals, and implementation records.
Audit planning, checklist development, execution support, findings documentation, and corrective action planning.
Pre-audit preparation, audit-day support, finding response support, corrective action documentation, and closure tracking.
Supplier qualification, supplier records, risk-based supplier controls, and supplier audit readiness.
Root cause analysis, corrective action planning, effectiveness checks, and closure support.
Practical implementation plans, timelines, ownership, task tracking, and rollout support.
Work with experienced consultants who understand your industry and challenges.
Receive straightforward outputs that your team can understand and use.
Build confidence with evidence-based systems and consistent processes.
Solutions designed for your organization — scalable and sustainable.
