Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.

No, thanks

BOOK A MEETING BOOK A MEETING
Sign In
sop-translation-services

The Critical Role of SOP Translation in Life Sciences

Standard Operating Procedures (SOPs) are essential documents that define consistent, repeatable workflows across pharmaceutical, biotechnology, and medical device operations. These documents form the backbone of GxP compliance and are required to support quality assurance, regulatory inspections, manufacturing consistency, and employee training.

In global operations, SOPs must be available in the local languages of employees and regulators. Accurate and consistent translation of SOPs is critical to ensure proper execution of procedures, alignment with quality systems, and adherence to region-specific regulatory frameworks such as FDA, EMA, PMDA, and ISO standards.

Mistranslated SOPs can result in serious compliance failures, including deviations, rejected audits, halted production, and costly product recalls. For companies operating in regulated life sciences environments, precise SOP translation is not optional, it is a regulatory requirement and a cornerstone of operational integrity.

Read More Read Less

Why SOP Translation Matters in Regulated Environments

In the life sciences industry, regulatory authorities such as the FDA, EMA, PMDA, and NMPA mandate that Standard Operating Procedures be available in the local language of each operational site. SOPs must be clearly understood by all personnel to ensure procedural consistency, minimize human error, and support full compliance with applicable regulations.

Accurately translated SOPs are integral to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and other GxP frameworks. They serve as the foundation for quality management systems, internal audits, employee onboarding, and manufacturing operations. Improper or unclear translations can compromise product quality, delay regulatory approvals, and result in failed inspections.

As life sciences companies expand globally, multilingual SOPs become critical for maintaining operational alignment across sites and for satisfying local regulatory expectations during cross-border audits. Clear and compliant SOP translation is essential for sustaining global manufacturing integrity and regulatory readiness.

Read More Read Less

Sesen’s Expertise in SOP Translation

Sesen specializes exclusively in translation and localization services for the life sciences sector. Our in-depth understanding of pharmaceutical, biotechnology, and medical device industries allows us to deliver accurate, compliant SOP translations that meet global regulatory standards.

We are certified to ISO 13485, ISO 9001:2015, and ISO 17100, ensuring consistent quality, documented processes, and translator qualifications aligned with industry best practices. Our SOP translation workflows support GxP compliance and are built to withstand scrutiny during regulatory audits.

With experience translating thousands of SOPs across drug development, manufacturing, and quality control functions, we are trusted by leading life sciences organizations to support both internal operations and international regulatory submissions. Each project is managed by trained linguists who are native speakers and subject matter experts, ensuring clarity, accuracy, and alignment with technical terminology.

Read More Read Less

Types of SOPs We Translate

Sesen provides specialized SOP translation services for a wide range of operational, quality, and regulatory functions across pharmaceutical, biotechnology, and medical device manufacturing environments. Below are examples of the SOP categories we support:

Instructions covering sterile processing, formulation, compounding, and cleanroom operations under Good Manufacturing Practice guidelines.

SOPs for equipment cleaning, facility disinfection, environmental monitoring, and validation of cleaning processes.

Documentation for in-process checks, product testing, deviation management, and quality audits.

Procedures for the calibration, qualification, and preventive maintenance of manufacturing and laboratory equipment.

Guidelines for completing, reviewing, storing, and archiving master and executed batch records.

SOPs supporting risk assessments, root cause analysis, corrective and preventive actions, and change control processes.

Standard procedures for label design, approval workflows, print checks, and final packaging activities.

SOPs for material handling, temperature-controlled storage, shipment verification, and supply chain traceability.

Documentation related to final product testing, release criteria, disposition, and regulatory sign-off.

Procedures defining training requirements, documentation, qualification tracking, and periodic retraining.

These SOP categories represent common translation needs across regulated life sciences sectors. We also support custom SOP formats, multi-site alignment, and region-specific compliance requirements.

Industry-Specific SOP Translation Capabilities

Sesen offers targeted SOP translation services tailored to the specific regulatory, technical, and operational requirements of different life sciences sectors. Our workflows are designed to support industry-specific terminology, document structure, and compliance expectations.

Our SOP translation services for pharmaceutical manufacturers focus on procedures that support Good Manufacturing Practice (GMP) compliance, sterile processing, product validation, and batch release. We align content with global regulatory frameworks including ICH Q7, FDA 21 CFR Part 211, and EMA GMP Annexes. For broader support across manufacturing documentation, see our pharmaceutical manufacturing translation services.

Sesen has extensive experience translating SOPs related to small molecule production, biologics manufacturing, and active pharmaceutical ingredient (API) processing. Our translators are trained in pharmaceutical terminology and understand the precise documentation standards required for regulatory inspections and quality audits.

For medical device manufacturers, we translate SOPs that support design controls, production processes, quality management, and post-market surveillance. This includes procedures for device assembly, sterilization, process validation, and software documentation in accordance with ISO 13485.

We ensure SOPs align with regional and international standards, including the EU Medical Device Regulation (EU MDR), FDA Quality System Regulation (21 CFR Part 820), and ISO 14971 for risk management. Our experience covers Class I, II, and III devices, diagnostics, and combination products requiring both drug and device expertise. Learn more about our medical device translation services for additional document types and compliance areas.

Sesen provides SOP translation services for biotechnology companies engaged in early-stage research, clinical development, and biologics manufacturing. These translations support quality systems, laboratory controls, bioprocessing, and regulatory submissions. Common procedures include cell culture handling, fermentation, purification, and biosafety protocols.

Our translations are aligned with regulatory frameworks such as FDA 21 CFR Parts 210–211 and 600 series, ICH Q10, and EMA advanced therapies guidance. We are experienced in supporting gene therapy, monoclonal antibody production, and other complex biologic modalities. All translations are handled by linguists with scientific expertise in molecular biology, bioengineering, and biomanufacturing processes.

We support CROs with SOP translation services that cover clinical trial operations, data management, pharmacovigilance, and regulatory documentation. These SOPs are essential for maintaining compliance with ICH GCP guidelines, FDA 21 CFR Part 312, and the EU Clinical Trials Regulation (EU CTR).

Sesen has translated SOPs for clinical monitoring visits, informed consent procedures, adverse event reporting, electronic data capture, and trial master file maintenance. Our linguists are trained in clinical trial workflows and understand the importance of terminology precision for audit readiness and sponsor compliance across global study sites.

Our Translation Process for SOPs

Sesen follows a structured, quality-driven process for translating Standard Operating Procedures to ensure linguistic accuracy, regulatory alignment, and consistency across all documents.

We begin with project scoping, where we assess document volume, source file formats, regulatory context, and language requirements. Glossaries and client-specific style guides are applied throughout the process to maintain alignment with internal documentation standards. We also offer dedicated support for glossary and style guide development to strengthen long-term consistency across your multilingual content.

Our team uses advanced translation memory (TM) systems and controlled glossary tools to promote consistency across recurring procedures, reduce turnaround times, and lower long-term translation costs. These technologies help maintain alignment across multiple SOPs, especially in multi-site or multilingual projects.

Each SOP undergoes a multi-step quality assurance process that includes translation, editing, and bilingual review. Final checks include in-context validation to ensure proper formatting, numbering, and compliance with SOP template standards. We also accommodate client revisions and facilitate final approval before delivering the content in the required format for direct integration into quality management systems or SOP libraries.

Read More Read Less

Languages Supported

Sesen offers SOP translation services in over 150 languages to help life sciences organizations meet global regulatory and operational requirements. We support all major regulatory markets, including North America, Europe, Asia-Pacific, Latin America, and the Middle East.

Our network of in-country linguists ensures contextual accuracy and regulatory alignment in the target language. Translations are handled by native professionals with expertise in pharmaceutical, medical device, and biotechnology terminology.

Commonly requested languages include:

  • Spanish (EU and LATAM variants)
  • French (France and Canada)
  • German
  • Japanese
  • Simplified and Traditional Chinese
  • Korean
  • Portuguese (Brazil and Portugal)
  • Italian
  • Polish
  • Turkish
  • Arabic
  • Vietnamese
  • Russian

We also provide region-specific localization to ensure compliance with language expectations in the EU, APAC, MENA, and LATAM regions. This precision supports workforce comprehension, regulatory audits, and global quality system alignment.

Read More Read Less

Integrated Translation Workflows Backed by Secure Technology

Sesen combines expert human translation with advanced technology infrastructure to deliver accurate, consistent, and secure SOP translations for life sciences clients. Our workflows are designed to meet the technical and regulatory demands of global manufacturing and clinical environments. Visit our page on translation technology and workflow solutions for more on how we support enterprise life sciences clients.

We use enterprise-grade translation management systems (TMS) to streamline project execution, enforce terminology consistency, and manage multilingual content at scale. Glossaries and client-specific style guides are applied throughout the process to maintain alignment with internal documentation standards and regulatory language requirements.

Where appropriate, and only upon client request, we offer hybrid translation models or machine translation post-editing (MTPE) for internal-use SOPs that do not require full regulatory review. All MTPE output is reviewed by qualified linguists to ensure baseline quality and coherence.

All translation activities are conducted within a secure, access-controlled environment. Our infrastructure is hosted on Amazon Web Services (AWS), offering end-to-end encryption, role-based access, and compliance with industry-standard data protection protocols.

Read More Read Less

SOP Translation for Global Audits and Inspections

Sesen supports life sciences organizations in preparing multilingual SOPs that meet the documentation standards required during regulatory audits and inspections. Accurate translation of SOPs is essential for demonstrating operational compliance and maintaining inspection readiness across global manufacturing and clinical sites.

Our team assists with both pre-inspection and post-inspection documentation workflows, helping clients localize, update, or back-translate SOPs in accordance with regulatory expectations. We ensure alignment between translated SOPs and supporting records such as employee training logs, deviation reports, and change control documentation.

Sesen has extensive experience translating SOPs and related quality documentation in support of audits conducted by the FDA, EMA, ANVISA, PMDA, and the World Health Organization (WHO). Our processes are designed to help clients maintain regulatory transparency, avoid delays, and respond confidently during international inspections.

Read More Read Less

Why Sesen

Sesen is a life sciences–focused language service provider with deep expertise in regulatory translation. Unlike generalist agencies, we work exclusively with pharmaceutical, biotechnology, and medical device companies, giving us a precise understanding of industry terminology, documentation standards, and compliance requirements.

Each project is managed by a dedicated translation lead with experience in quality assurance, document control, and regulatory workflows. Our team provides structured communication, including weekly progress updates and risk-based tracking for critical timelines and deliverables.

Clients trust Sesen for our ability to deliver accurate, audit-ready SOP translations that align with internal quality systems and global regulatory expectations. We are proud to support leading organi.

Read More Read Less

Client Testimonials and Use Cases

Sesen’s SOP translation services have supported successful regulatory audits, global manufacturing launches, and multilingual workforce training initiatives for leading life sciences organizations. Below are examples of how our clients benefit from partnering with us:

“Sesen helped us translate over 200 SOPs into seven languages ahead of a multi-country regulatory inspection. The translations were accurate, well-formatted, and delivered on time. Our team passed the audit without a single documentation issue.”

— Global Quality Director, Top 10 Pharmaceutical Company

“Thanks to Sesen’s SOP translations, we were able to accelerate the onboarding process at our new APAC manufacturing site. The training team appreciated how clearly the content reflected local terminology and regulatory expectations.”

— Training & Compliance Manager, Biotechnology Firm

“We needed to align SOPs across multiple CRO partners for a global clinical study. Sesen ensured consistent terminology across all translations and helped us avoid delays related to document discrepancies.”

— Clinical Operations Lead, Mid-Sized CRO

These examples reflect our ability to reduce regulatory risk, speed up global site readiness, and enhance SOP-driven training outcomes. Full case studies and client references are available upon request.

Frequently Asked Questions

We accept SOPs in a variety of formats, including Microsoft Word, PDF, Excel, XML, InDesign, and structured content formats such as DITA. Our team can also work with document management systems to extract and return content in the preferred layout.

Yes. Sesen provides certified translations upon request, including translator affidavits, certificates of accuracy, and notarized statements when required for regulatory submissions or legal documentation.

Our SOP translations follow strict quality assurance protocols aligned with ISO 17100 and ISO 13485 standards. We use trained life sciences linguists, implement bilingual review, and verify that terminology complies with regulatory frameworks such as FDA, EMA, PMDA, and WHO guidelines.

Yes. We specialize in multi-market localization and can manage simultaneous SOP translation into multiple languages while adapting content to regional terminology and regulatory requirements. This is especially useful for global site rollouts and centralized training programs.

Turnaround times depend on volume, language pairs, and regulatory complexity. For most SOPs, we offer delivery within 3 to 5 business days, with expedited options available for urgent needs. Large batches can be scheduled in phases to meet client rollout timelines.

Get Started with Expert SOP Translation

Ready to translate your SOPs with accuracy, speed, and regulatory confidence? Contact Sesen to request a customized quote or schedule a consultation with our life sciences translation specialists.

REQUEST A QUOTE REQUEST A QUOTE
SPEAK TO AN EXPERT SPEAK TO AN EXPERT