We specialize in pharmaceutical translations for PILs, SmPCs, Protocols and ICFs and their amendments.
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.
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:
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.
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.
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.
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).
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:
Contact us now to discuss your pharmaceutical translations project and receive a cost estimate.