When it comes to registering a new product in compliance with EU legislation, it is necessary to include a report or statement in the specific subsection of your eCTD submission. This step is mandatory, but the approach can vary depending on the nature of your product.

Fortunately, there are multiple options available to meet the requirements of this section. Regulatory agencies have become more flexible over time, accepting different types of reports depending on the product. To gain a better understanding of the process and its significance, please refer to the information provided below. Making the right strategic choice is vital for achieving a secure, efficient, and cost-effective approval from the regulatory agency.

● Medical translations
● Legalized translations
● Specialized in:
● PL, SmPC and labelling
● Literature articles
● PHV: adverse reactions and events
● Pharmaceutical marketing
● Full dossiers

The precise translation of these documents is crucial to maintaining information accuracy and ensuring global compliance. A single error in translation can lead to severe consequences, such as regulatory non-compliance or product liability issues. Consequently, it is vital for pharmaceutical companies to engage skilled and experienced translators to meet their translation requirements, guaranteeing seamless communication and a positive brand image.