Over the years, we have successfully passed a large number of audits by health authorities, both in oral and sterile products. Among them, there are three FDA inspections, the two most recent completed without any observations.
Our practical experience allows us to offer complete support to prepare your documentation, your equipment and your processes, with the aim of facing any regulatory inspection with guarantees.
- FDA (Food and Drug Administration)
- EMA (European Medicines Agency)
- AEMPS (Spanish Agency for Medicines and Health Products)
- KFDA (Korea Food and Drug Administration)
- ANVISA (National Health Surveillance Agency)
We carry out a preliminary audit as a diagnosis, we propose an action plan with the necessary improvements to be able to successfully pass a health authorities audit, and we can even train your entire personnel to successfully undergo the audit. We can also help you set up the necessary internal organization to prepare your company, implement the required corrective and preventive actions, and accompany you throughout the process if you wish.
We adapt to the aplicable GxP regulations in each case (GMP, GDP, GLP, among others) and collaborate with your team to ensure compliance with the documentary requirements. Our methodology combines on-site experience with up-to-date knowledge of regulatory frameworks, to ensure that each audit becomes an opportunity and not a threat.
We accompany you side by side throughout the process, always by your side to offer you security and peace of mind.
In addition, we can also support you in preparing audits from your customers (supplier audits), integrating audit preparation into a broader compliance and continuous improvement strategy.