Pharmaceutical Translations

In accordance with the specifications of EOF (National Organization for Medicines), as well as European and international organizations for medicines

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Specialization

We specialize in the translation of pharmaceutical documents such as PILs, SmPCs, clinical study protocols and ICFs and their amendments.

Quality Assurance

The members of our pharmaceutical translation team have many years of experience in the pharmaceutical industry, undertaking translations for major international and domestic pharmaceutical companies.

International Experience

ACM Translations works with Greek pharmaceutical companies for the translation of dossiers into foreign languages for the approval of medicinal products by the European Medicines Agency (EMA), as well as by health authorities of third countries.

Translation of pharmaceutical texts

Pharmaceutical translations include two non-negotiable requirements: full linguistic familiarity and knowledge of scientific terminology, as well as compliance with the standards and regulatory frameworks of the regulatory bodies. Through its specialized team, ACM Translations possesses the experience and scientific knowledge allowing us to responsibly undertake any pharmaceutical translation.

Our translation agency has gained the trust of many Greek and multinational companies in the pharmaceutical sector, undertaking the translation of documents such as:

Patient Instruction Leaflets (PILs) complying with European QRD standards
Summary of Product Characteristics - SmPC
Informed Consent Form - ICF
Protocols and results of clinical studies and amendments thereto.

PHARMACEUTICAL TRANSLATIONS

Specializing in the translation of pharmaceutical documents

From regulatory affairs in the EU and other foreign countries to the accurate translation of pharmaceutical documents, ACM Translations’ team has in-depth experience in a variety of pharmaceutical translations that will enable your pharmaceutical product to enter foreign markets. Our team is made up of translators with exclusive expertise in the pharmaceutical industry, with relevant degrees and extensive experience in pharmaceutical translation.

Knowledge of EOF specifications and requirements

Large pharmaceutical companies abroad trust us to translate into Greek all the necessary documents and materials for the approval process of their product by EOF.

Specialization in European QRD standards

The European QRD (Quality Review of Documents) standards for the authorization of human medicines established by the EMA (European Medicines Agency) require specific terminology and specifications for a pharmaceutical product to receive authorization.

At ACM Translations we are familiar with the regulations and we have experience in QRD translations, so we are able to translate the information pertaining to your medicine in the manner provided for and with the correct terminology. In addition, ACM Translations' pharmaceutical translation team remains up to date on any changes to the requirements of the European Medicines Agency.

Knowledge of regulatory affairs in the pharmaceutical sector

In addition to translators specialized in pharmaceutical science, we also work with expert regulatory affairs consultants who are familiar with all the specifications that translated forms must meet in accordance with the extremely strict requirements of the European Medicines Agency (EMA) in terms of content, terminology, and format. In addition, when required, we closely follow the suggested terminology of the American MedDra (Medical Dictionary for Regulatory Activities) and the European EDQM (European Directorate for the Quality of Medicines and Healthcare).

International experience in pharmaceutical approval specifications

Approval of pharmaceutical products by foreign drug agencies and regulatory bodies is a complex process. ACM Translations is your ideal partner, thanks to:

attention to the smallest detail on every form accompanying your file
compliance with the strict time limits for submission
experience in submitting pharmaceutical dossiers for approval by organizations such as the US Federal Drugs Association (FDA)
possibility of drafting a CTD (Common Technical Document). This pertains to the internationally accepted method of submitting the documents related to the approval process of medicinal products in the countries of the EU, the U.S.A., Japan etc.