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Pharmaceutical Translations

Based on the specifications and templates issued by the EMA and USFDA.

Specialization

We specialize in pharmaceutical translations for PILs, SmPCs, Protocols and ICFs and their amendments.

Quality Assurance

Our Quality Assurance system consists of consecutive checks performed by specialized translators and regulatory affairs consultants to ensure the accuracy and quality of our pharmaceutical translations. 

Global Experience

We work with Greek pharmaceutical companies to translate their marketing authorization dossiers into foreign languages for approval by Medicines Agencies of EU member and non-member states.

Translation of pharmaceutical texts

Pharmaceutical translations have two critical requirements: use of pharmaceutical terminology and compliance with the specifications and legal requirements of regulatory bodies. ACM Τranslations has both the experience and know-how to translate pharmaceutical documents.

    We can translate into more than 100 languages:

    • Patient Instruction Leaflets (PILs)
    • Summaries of Product Characteristics (SmPCs) 
    • Clinical study documents and amendments (Protocols, Informed consent forms, Investigator's Brochures, Serious Adverse Event reports, etc.) 
    • Patent applications

    Specialization in pharmaceutical translations

    Our pharmaceutical translations team consists of linguists trained in pharmaceuticals translations, with a minimum of three years of experience in this translation field. This ensures our team has the required knowledge and experience to handle a wide range of pharmaceutical translations of documents ranging from regulatory affairs in EU member states or foreign countries to translation of information material, to allow your Pharmaceutical product to be out-licensed in foreign markets. 

    National Organization for Medicines (N.O.M.) and other Medicines Agencies specifications and requirements

    Leading international pharmaceutical companies entrust us with translating into Greek all the documents necessary for submitting their products for approval at the Hellenic National Organization for Medicines. Our experience with the procedures and the required QRD templates ensures a smooth experience for our clients.

    Specialization in European QRD templates

    The European QRD (Quality Review of Documents) templates for the approval of human medicinal products drafted by the European Medicines Association (ΕΜΑ) require the use of specific terminology and phrasing in order for a product to be approved.  At ΑCM Translations we are very familiar with these such regulations and have vast experience in providing translations based on QRD templates.

    Know-how of regulatory affairs in the pharmaceutical field

    Apart from our translators who specialize in Pharmaceutical science, we also work with special regulatory affairs consultants, who have an insight into all the specifications to be met by translated documents  in accordance with the rigorous requirements of the European Medicines Association (ΕΜΑ) as per content, terminology and form.  What is more, when required, we loyally conform with the terminology suggested by the American MedDra (Medical Dictionary for Regulatory Activities) and the European EDQM (European Directorate for the Quality of Medicines and Healthcare).

    Experience with International requirements for the approval of human and veterinary medicines

    The approval of human or veterinary pharmaceutical products by foreign Medicines Agencies and regulatory authorities is a complicated process. ACM Translations is your perfect partner for this, since:

    • we pay attention to the tiniest detail for every supporting document in your dossier
    • we can meet very strict submission deadlines
    • we have experience in the submission of pharmaceutical dossiers for approval by organizations like the Federal Drugs Association (FDA)
    • we can translate CTD (Common Technical Document) forms

    Contact us now to discuss your pharmaceutical translations project and receive a cost estimate.