CORE SERVICES
Regulatory and Quality Audits
Regulatory and Quality Audits
Ensuring transparency, traceability, and continuous improvement
In a dynamic and increasingly demanding regulatory environment, audits are a key tool to ensure transparency, traceability, and continuous improvement.
At LAMA, we support companies in the healthcare sector through comprehensive audits designed to identify gaps, optimize processes, and ensure compliance with local and international regulatory requirements.
Scope of our services:
We perform both internal and third-party audits, tailored to the specific needs of each client:
• Supplier audits, evaluating the compliance and performance of material, packaging, or service providers.
• Distributor and local representative audits, verifying adherence to contractual and regulatory responsibilities.
• Internal compliance audits, focused on preparation for inspections by health authorities or licensors.
Benefits:
• Early detection of nonconformities and reduction of regulatory risks.
• Enhanced control over outsourced processes and the overall supply chain.
• Strengthened relationships with suppliers and distributors through objective evidence.
• Solid preparation for audits conducted by health authorities, licensors, or ISO certification bodies.
Our methodology:
1. Planning: definition of scope, objectives, and schedule in collaboration with the client.
2. Execution: interviews, document review, and on-site or remote evaluation.
3. Analysis: identification of findings, risk classification, and proposal of corrective actions.
4. Reporting and follow-up: presentation of the final report and support during implementation of improvement plans.
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LAMA SOLUTIONS LLC