Assistance in the preparation of robust submissions, interactions with regulatory authorities, and comprehensive risk assessments before authorization. Additionally, our post- authorization support ensures compliance, monitors safety, and optimizes your product’s performance in alignment with Greek and international regulations.

Our team offers a comprehensive suite of services, from compiling the necessary documentation and coordinating submissions to facilitating communication with regulatory authorities.

Our support extends to marketing authorization renewals, ensuring continuous compliance with evolving regulations.

Related documents to Health Authorities – related documents to Health Authorities – compiling essential documentation to guiding you through submission processes.

Preparing, validating, and submitting electronic dossiers in compliance with the latest regional and international guidelines.

All pharmaceutical products which receive marketing authorisation in the EU are to be accompanied by summaries of product characteristics (SmPCs), patient information leaflets (PILs) and labels. SmPCs are official descriptions of drugs. They include information such as: pharmaceutical form, indications, method of administration, pharmacological properties, etc. Product leaflets also cover some of this data, but their main role is to provide intelligible and user-friendly information to patients, so they tend to be less specialized in terms of medical terminology. Labels are used for drugs’ packaging.

Conducting a reader usability test is a crucial step in ensuring that the intended audience can easily comprehend and engage with your written content. By investing time and effort into this vital process, you unlock valuable insights into the readability, clarity, and effectiveness of your text.