Professional Translation Services for Regulatory Affairs
Stepes (/’steps/) provides certified, regulation-compliant language translations for regulated content in all Asian and European languages. We help pharmaceutical companies, medical device manufacturers, and CRO firms achieve multilingual regulatory compliance, one accurately translated medical document at a time.
Regulated Content Translated Right
Are you a pharmaceutical company, medical device manufacturer, or CRO firm in need of translating clinical documents with the highest quality to meet international regulatory requirements? Look no further than Stepes. We provide ISO 13485 certified translation services to help our clients achieve international regulation compliance with confidence. As a heavily regulated industry, life sciences companies must accurately translate a variety of technical content to meet local regulatory standards and gain international market approval of new drugs or medical devices. Stepes has one of the largest teams of professional medical translators and multilingual life sciences subject matter experts with in-depth experience translating regulated content, delivering the best linguistic accuracy and technical precision.
In todays’ global regulatory environments, quality language translations can make or break the international business of life sciences companies. Stepes employs a variety of linguistic quality assurance and multilingual content compliance procedures perfectly tailored to the unique needs of language localization in medical product development, clinical trial, and safe drug manufacturing. Our regulatory translation solutions can be implemented as a standalone service or integrated within our clients’ clinical best practices such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Quality Management Systems. We take the stress out of translating technical content accurately between English and Spanish, English and Chinese, English and Japanese so our clients can confidently manage multilingual international regulatory submissions and audits. In addition to having experienced linguistic experts, Stepes also leads the language industry with next-gen linguistic validation technologies to achieve the best localization efficiency with reduced translation cost. Talk to one of our multilingual regulatory affairs consultants today and raise your medical translation performance to a higher level of accomplishment and ROI.
Translation of Regulatory Submissions for FDA
In today’s global clinical research and drug development marketplace, many clinical trials, as well as drug manufacturing operations are conducted internationally. The U.S. FDA has several regulations (such as CFR – Code of Federal Regulations Title 21) that require clinical documents submitted in foreign languages to be accurately translated into English. This where Stepes can help. We offer ISO 9001 certified regulatory translation solutions between English and Chinese, English and German, English and Japanese, and many other languages to help simplify the FDA compliance process while ensuring accurate, on-time submissions. To learn more about Stepes expert clinical trial translation solutions, please click here.
Regulatory Translation Services for EMA
Stepes provides high-quality and reliable translation services in all of the EU 24 languages for regulatory submissions to The European Medicines Agency or EMA. For pharma companies to market new drugs in the European Union, a variety of technical information must be accurately translated into the languages of the EU countries in which the drug or medical device will be marketed. Specifically, we have in-depth experience translating Product Information Leaflets, Labelling, and Summary of Product Characteristics that are standard requirements of new drug application submissions for EMA review and approval.
Regulatory Submission Translation for NMPA
Are you looking to expand your pharmaceutical business in China? Chances are you need a variety of clinical submissions translated between English and Chinese to meet local regulatory requirements of The National Medical Products Administration (NMPA), formerly SFDA. We have a large team of expert English-Chinese medical translators who are professionally trained to translate clinical trial documents, such as COAs (clinical outcome assessments) and PROs (patient reported outcomes), with accuracy and speed. One of Stepes’ unique strengths is that we helped Pfizer translate MedDRA (Medical Dictionary for Regulatory Activities) between English and Chinese that contained hundreds and thousands of medical terms which were approved and accepted by SFDA for official use. We’re literally the authority in Chinese regulatory translation services.
Regulatory Translation for PMDA
Stepes has strong experience translating medical device and pharmaceutical content to meet the Japanese language requirements of Japanese pharmaceutical affairs. The Japan Pharmaceuticals and Medical Devices Agency or PMDA has detailed regulations and rules requiring all foreign medical product applications to be submitted in Japanese. The good news is, with Stepes, translating your clinical trial documents or medical device IFUs with quality and speed doesn’t have to be a drag on your Japanese marketing success. We have the linguistic capabilities, regulatory experiences, and cutting-edge language technologies to help accelerate your Japan life sciences business success across linguistic barriers. To learn more about Stepes comprehensive Japanese medical translation offerings, please click here.
Linguistic Validation for Regulatory Affairs
Professional language translation for regulatory affairs requires the most rigorous localization quality assurance process to deliver consistent, reliable results. Linguistic validation is a method of choice by many translation companies to help CROs and their pharmaceutical sponsors meet international regulatory quality standards by delivering the most accurate language translations of COAs and PROs. Stepes has the linguistic resources, mature localization processes, and cutting-edge translation management technologies to provide top-notch linguistic validation services in all major European and Asian languages. To learn more about Stepes comprehensive linguistic validation solutions, please click here.