Translation of pharmaceutical sector regulations: precision, compliance and efficiency

In the pharmaceutical sector, the translation of regulatory documents is not simply a linguistic issue: It is a question of compliance, rigour and responsibility. Each word must accurately reflect the original intention, each term must be validated in accordance with the terminology accepted by health authorities, and content must be delivered in compliance with strict deadlines and regulated procedures.

In this context, an incorrect or ambiguous translation can require much more than a revision: it may delay approvals, generate nonconformities or, in the worst case, compromise a patient's safety.

At ATLS, we work closely with Regulatory Affairs, Legal and Compliance departments to help them manage large volumes of multilingual documents with maximum precision. Our language solutions are scalable, specialist and adaptable, and are designed to integrate with the internal workflows of each organisation, in compliance with the regulatory requirements of the EMA, FDA and other international agencies.

We have native-speaking translators who specialise in the pharma sector, state-of-the-art technology and certified processes that ensure consistent terminology, confidentiality and traceability at each project stage.

Guaranteed compliance in each phase

At ATLS, we collaborate with some of the world's most renowned pharmaceutical laboratories and companies, providing language support for the translation of documents that are highly sensitive and subject to strict regulatory controls.

Our experience covers a wide range of key materials in the life cycle of a medication or medical product, including:

• Regulatory dossiers for marketing authorisation applications (MAA/NDA), variations and extensions
• Labels and packaging material, adapted to the specific requirements of each national authority
• Data sheets (SmPC), leaflets (PIL) and external labels, in accordance with the formats required by the EMA, FDA and other bodies
• Legal contracts, informed consents and ethical documents related to clinical trials
• Safety reports, pharmacovigilance updates (PSUR/DSUR), periodic reporting and adverse event notifications

Our in-depth knowledge of European and international regulatory processes and standards enables us to localise technical content while respecting the original intention and complying with the style, structure and terminology guides of each jurisdiction. For procedures at centralised, decentralised or national level, we ensure that all documents are linguistically aligned and officially in accordance with the expectations of the corresponding regulatory body.

Why do pharmaceutical companies choose ATLS?

When outsourcing the translation of critical documents, pharmaceutical companies look for a supplier with technical knowledge, operational reliability and the ability to adapt to their processes. At ATLS, we offer precisely that:

Native-speaking and specialist pharma translators

We work exclusively with professional native-speaking linguists who have scientific training in areas such as pharmacy, biology, chemistry or medicine, and who have experience of regulatory, medical and legal environments. This enables us to ensure that our translations demonstrate a thorough understanding of content, use precise terminology and have been accurately adapted to the requirements of each document.

Advanced language technology

We use AI tools, customised neural translation engines and native plugins that integrate our services directly into the customer's document management systems (CMS, TMS, eCTD, etc.). This translates into faster delivery times, fewer human errors and greater linguistic consistency throughout the document cycle.

Renowned quality certifications

We are certified under the main international standards that regulate translation processes:

• ISO 17100: professional translation services
• ISO 9001: Quality management systems
• ISO 18587: machine translation post-editing

These certifications enable us to guarantee robust, auditable processes that have been adapted to regulated environments, where traceability and validation are of fundamental importance.

Less work for the customer

We adapt our processes to the internal workflows, required formats, technical glossaries and corporate templates of each laboratory or CRO. Our team acts as a natural extension of your department by anticipating potential obstructions, managing last-minute changes and ensuring a smooth experience, with minimal customer involvement.

Key service areas

Regulatory Affairs

At ATLS, we specialise in the translation of regulatory affairs, an area where accurate terminology, document structure and strict deadlines are critical. We translate complete files for marketing authorisation applications (MAA, NDA), variations, renewals and post-authorisation communications, in full compliance with the regulatory guides of the EMA, FDA and other international agencies.

Our team combines linguistic expertise and technical knowledge to offer clear, coherent translations and checklists. This helps minimise risks when submitting regulatory documents and speeds up the validation and approval processes.

✅ Pharmaceutical technical translation with regulatory guidance
✅ Adaptation to the formats and terminology required by each jurisdiction
✅ Certified and traceable processes

Product labelling and material

The translation of pharmaceutical labels, leaflets and packaging materials must meet two prerequisites: local language and regulatory requirements; and clear and safe patient communication.

At ATLS, we ensure that all product information –from external labels and leaflets (PIL) to data sheets (SmPC)– have been correctly translated and validated. We also coordinate national linguistic reviews when required by the health authorities within a framework of decentralised or centralised procedures.

✅ Medical translation that focuses on usability and accuracy
✅ Controlled and standardised terminology
✅ Compliance with QRD guidelines, PLR and local requirements

Safety and pharmacovigilance

Medical translation in the field of pharmacovigilance requires a particularly rigorous approach, as it involves sensitive documents that are associated with patient safety and risk management.

We translate adverse reaction reports, PSUR, DSUR, periodic reports, urgent communications and risk management plans using strict terminology and format control. Our processes ensure compliance with local and international regulations and quick delivery, even in multilingual and high pressure contexts.

✅ Pharmaceutical technical translation that focuses on safety
✅ Integration with quality management systems and pharmacosurveillance platforms##44441## ##44441##✅ Quick response for urgent cases or tight regulatory deadlines

Strategic translation for a sector that does not allow errors

In an environment as regulated and demanding as the pharmaceutical industry, an incorrect translation is not a simple setback: It can result in a refusal to grant authorisation, sanctions for regulatory non-compliance, and even compromise patient safety.

That's why, at ATLS we view pharmaceutical translation not just as another language service, but as a strategic link within the sector's value chain. Whether it is medical translation, regulatory affairs or pharmaceutical technical documents, our approach is based on three key foundations:

• Highly specialist native-speaking experts, with in-depth knowledge of scientific, medical and legal language
• Smart technology that speeds up processes, improves consistency and reduces delivery times
• Certified and auditable processes that are aligned with the most demanding ISO standards in the sector

Our goal is clear: to help you meet every regulatory requirement on each market, with no margin for error, no friction and without putting the quality or integrity of your documents at risk.

With ATLS, your critical content is in the hands of a partner who understands your challenges, speaks your language and protects your reputation.

Translation as a key element in regulatory affairs processes Contact us today to find out how we can help you optimise your multilingual regulatory flows with quality, accuracy and security.

Frequently asked questions about pharmaceutical translations

Karen Aliaga