TRANSLATION FOR THE PHARMACEUTICAL
INDUSTRY: Optimizing Quality, Cost &
Time-to-Market
Quality Translations Are Critical to Achieving Regulatory Compliance.
When it comes to translating pharmaceutical documents, vetting and securing a translation company of the highest quality with industry-specific
regulatory expertise can be a tremendous challenge. However, it is also a critical factor for success. Translations must achieve strict compliance with
a host of regulatory bodies, such as the U.S. Food and Drug Administration (FDA); the European Medicines Agency (EMA); and Japan’s Ministry of
Health, Labour and Welfare (MHLW). As pharmaceutical companies strive to reduce R&D costs (including translation expenditures) and accelerate
time-to-market, the demand for quality materials that maintain stringent adherence to source documents and terminology is a top priority. These
challenges demand an all-in-one, industry-focused solution that will reduce translation costs as well as guarantee integrity, consistency, coherence
and accuracy of translations. Only a proven, quality-intensive translation process – one that incorporates up-to-date glossaries and style guides – will
avoid unnecessary rounds of revisions and produce materials aligned with each client’s expectations.
SeproTec Combines Compliance Expertise and Efficiency to
Ensure Quality.
Leveraging decades of experience, SeproTec has developed a unique process that integrates technology and translators in a workflow designed
to maximize and streamline the translation process, with a focus on increasing quality. The translators at SeproTec Multilingual Solutions are
screened, continually tested and specifically profiled to meet the unique quality and regulatory compliance requirements of the pharmaceutical
industry – for all languages. Before being approved, our translators must pass 15 test projects, after which all jobs undergo systematic double checks,
exhaustive sign-offs, extensive quality checklists and review by project managers – all of whom are linguists.
We are able to ensure the highest quality deliverables for pharmaceutical clients by building a team of individual freelance translators who
are subject matter experts and familiar with European Union (EU) regulations and the relevant national transpositions of those regulations.
This approach ensures more consistent quality and closer control over the workflow. To standardize review criteria and establish consistency across
all countries, we provide translators with templates based on EMA guidelines for terminology, structure and title translation. The ultimate test of
quality comes when we present validators with translated sample documentation. We only employ translators who have met the full expectations
of our clients.
SeproTec’s quality department is focused on monitoring quality metrics, such as our outstandingly low incident rate of 0.16 percent. The quality
of every deliverable is also supported by an equal commitment to confidentiality and security. Confidentiality agreements are supplemented
with a highly secure IT infrastructure, strict security protocols and backup policies. An ISO-certified company, SeproTec further elevates quality and
continuity by enabling clients to choose their preferred translators, who are assigned an ID code – a practice uncommon in our industry.
As a one-stop, high-quality solution offering a single point of contact for your account, SeproTec is able to streamline communications and provide
end-to-end project management services that reduce translation costs and accelerate time-to-market. Optimized translation memories, as
well as client-approved glossaries and style guides, support SeproTec’s exacting, industry-specific quality standards. And with offices strategically
located throughout Europe, the United States and Asia, you’ll experience 24/7, around-the-clock responsiveness.
TRANSLATION PROCESS FOR PHARMACEUTICAL PROJECTS
Acceptance of
quotations and
creation of Purchase
Order
ABOUT
SeproTec
Translation
expert Translator
using caT tools
customer
SeproTec is a Multilingual Service Provider
from the Sepro Group with more than 25
Receipt and
analysis of source
Revision
& submission of
quotations
expert reviser
using caT tools
project manager
years of experience providing translation and
interpreting solutions and ranked among the
Top 40 Language Service Companies in the
world (Common Sense Advisory, 2014). We use
WORKFLOW
Implementation
of customer
feedback
and update
of reference
material
the most advanced translation management
technology available today to maximize
DTP and layout
expert dTp
operator
Translation
Team
productivity and quality, and our dedicated
customer-specific teams work with over 380
employees and 4500 freelancers 24/7 to
guarantee satisfaction.
Review and
feedback
checks and sign off
customer
project manager
Headquarter Offices
Up until now, SeproTec has completed in excess of 5,000 pharmaceutical projects and 30 million translated words in more than 250 different language
combinations for more than 300 clients. With our wide-reaching experience, we provide a range of full-service solutions to clients across the pharmaceutical,
veterinary, food and beverage, and biotechnology industries.
In the pharmaceutical industry, SeproTec covers a wide range of translation services for:
Clinical Trial Protocol (Working Protocol)
Patient Information Pamphlets
Informed Consent Forms
Amendments to Working Protocol
Protocol Amendment Signatures Form
Frequently Asked Clinical Questions (FAQs)
SPC, Labeling and Package Pamphlets
We also provide translation services for articles for publication in medical magazines; translation of medical articles and reports; prescribing information materials;
therapeutic indication training materials and training manuals; PowerPoint presentations about the release of new drugs; posters and campaign materials about new
drugs; agreements for the performance of clinical trials; and export authorization certifications.
SEPROTEC IS YOUR GLOBAL LANGUAGE SOLUTIONS PARTNER
[email protected]
Worldwide offices. To locate your nearest office please visit our website
www.seprotec.com