Audits

Continuous improvement and Quality

We carry out specialized and tailored audits, both internal and external, that not only evaluate compliance with regulations such as GMP, GDP, ISO 13485, ISO 9001 o ISO 14001, but also serve as a starting point to establish a structured and efficient improvement plan.

Whether you're auditing a supplier, a contract manufacturer (CDMO), an in-house facility, or a new strategic partner, our team can help you.

We can also turn auditing into an opportunity to strengthen quality, optimize processes, and prepare your company to face audits from clients or regulatory agencies with complete confidence.

In addition, we have qualified auditors with international experience, and a network of contacts that allows us to coordinate audits anywhere in the world, either individually or shared.

Supplier Audits

We carry out audits of national and international suppliers, whether of raw materials, excipients, packaging materials, services, intermediate products or others. These audits, mandated by GMP and other regulatory frameworks, help ensure that your suppliers meet the required standards and mitigate critical risks in the supply chain.

In addition, if several clients need to audit the same supplier, we organize shared audits to reduce costs and increase efficiency, always respecting the confidentiality and interests of each company.

Shared Audits

Shared audits are a collaborative and cost-effective solution for auditing common suppliers while reducing costs. We help you find other clients interested in the same audit, coordinate the process and establish agreements on the criteria, scope and use of the results.

With this model:

  • Operating costs are significantly reduced
  • Duplication of audits to the supplier is avoided
  • Collaboration between companies in the sector is promoted

CMO Audits

If you work with CMOs (Contract Manufacturing Organizations), it is essential to ensure that they manufacture their products in compliance with current regulations. We audit your facilities and your quality system to verify that they meet the standards required by the regulatory authorities and by your own quality policy.

Why trust us?

  • International experience in regulated audits
  • Technical, rigorous and client specific approach
  • Comprehensive, clear and actionable reports
  • Possibility of individual or shared audits

Do you need to audit a supplier, a CMO, or a strategic partner?

We help you verify compliance, ensure quality, and protect your supply chain.
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Frequently Asked Questions (FAQ)

What kind of audits do you offer?
We audit suppliers, contract manufacturers (CMOs), strategic partners and internal quality systems. These audits can have different approaches: regulatory compliance (GMP, GDP, ISO), technical assessment, documentary verification or diagnosis prior to a client or regulatory agency audit.
Can you audit suppliers located in other countries?
Yes, we can travel to almost any country. We adapt the approach to the local regulatory context and the standards required by your clients or by the relevant health agencies.
What are shared audits and what are the benefits?
Shared audits allow multiple companies to audit the same supplier by sharing costs and results (under confidentiality agreements). It is an efficient and economical solution, especially useful when the supplier receives multiple audit requests.
Do you also audit internal facilities as part of a quality diagnosis?
Yes. We can audit your own quality system as a starting point for establishing an improvement plan. This type of internal audit allows deviations, risks or critical areas to be identified before an inspection or as part of a continuous optimization process.
What does the audit report include?
Our reports include an objective and detailed assessment and improvement opportunities ranked by criticality. We can also accompany you in the root cause analysis, the definition and implementation of corrective and preventive actions (CAPAs), as well as in the subsequent follow-up.