REGULATORY AFFAIRS REGULATORY AFFAIRS

The pharmaceutical industry is a fully regulated business model. Processing authorisation applications is one of the main duties of the regulatory affairs department and is essential for obtaining product market access.

No medicine can be marketed without prior authorisation from the relevant healthcare authorities. The requirements for placing a product on the market can vary depending on the product type (medicines, healthcare products, cosmetics, food supplements, etc.).

For example, the European Medicines Agency requires all summaries of product characteristics, patient information leaflets and labelling, among other materials, to be provided in the languages of all the member states where the product will be sold. Obtaining licenses in other countries around the world can mean complying with distinct linguistic requirements set by the competent authorities.

Due to the technical, confidential and regulatory nature of the different documents and texts that are translated, we ensure that our translators and proofreaders are trained in both the specialised vocabulary and the procedures described in the texts to make the end translation clear, concise and faithful to the original.

REGULATORY DOCUMENTS

• Quality reports
• Therapeutic positioning reports (TPR)
• Standard operating procedures
• Adaptation of summaries of clinical trials for laypersons
• Usability testing

• Batch analysis
• Manufacturing validation protocols
• Labelling
• IFUs (Information For Use)
• Patient information leaflet
• Product characteristics

• Biocompatibility evaluations
• Process validations
• Clinical and preclinical expert reports
• Process and clinical study protocols
• Registration dossier
• Risk assessment

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