We offer Japanese Translation Services, Japanese English Translation Company
Your Translation Partner

Regulatory
Submissions

Regulatory Submission

With effective and value-abiding translations, it gets easier for a pharmaceutical company to meet the market’s regulatory standards and expectations. A successfully constructive translation enables a business to achieve faster approval for their medical and health products. Ulatus has been serving companies in the heavily regulated life science industry, with accurate and high quality translations. We have been providing translations with highest quality and precision to various segments: Healthcare, Pharmaceutical, Biotech, Medical Devices, and more. Having a dedicated expert team enables us to deliver regulatory translations with high standards for both medical and health products. This team of translators also holds an extensive industry experience of working with regulatory agencies like FDA, EMA, CFDA, and PMDA. With language and subject expertise, our life science specialists ensure your regulatory documents meet local regulatory standards and are approval-ready.

Life Science Localization
Life Science Localization

Helping you overcome all challenges

Regulatory compliance is not just the key to acquire product licenses, but also the stepping-stone to access new markets. Ulatus’ localized regulatory submissions translation service builds the target language portfolio as explicit as the source language to gain a greater competitive advantage in the market. We manage the various regulatory documents with care and accuracy to protect your investments and ensure patient’s health. With an accurately localized content document, it becomes effortless to convey the essence of your product’s regulatory terms to the authoritative agencies. We overcome regional barriers and present the product’s information in a way that the authority understands and identifies with the text correctly. As also guaranteed, our regulatory submissions translation services delivers your message flawlessly and ensures compliance along with effective communication in the target market.

A list of documents which we translate

  Instructions for Uses (IFUs)

  Summary of Product
Characteristics (SmPC)

  Packaging

  Labeling

  Regulatory Correspondence
  Package Information Leaflets (PILs)

  Chemistry, Manufacturing and Control Documentation (CMC)

  Patient Prescribing Information

  Common Technical Documents (CTDs)

  Quality Review Documents (QRD)
  Pharmaceutical Product Information

  Regulatory Dossiers

  Standard Operating
Procedures (SOPs)

  Validation Documents

WHY ULATUS?

Discipline specific specialized translators

Experienced linguists with knowledge of International Regulatory Authority requirements

In-built proprietary technology for accurate translation

24*7 available support

Efficient balance of price, time and quality

ISO and ISMS compliant

Knowledge of multiple of CAT tools for consistency and cost

Our Clients

 

Contact Us

Our team of experts

We ensure your documents are translated accurately
Translator Tc131: japanese translator, professional japanese translation
Translator Tc131
  • Academic experience backed by strong professional experience, this translator has vast experience in the field of biochemistry and molecular biology. He has more than 8 years of translation experience. He is an American English native and is fluent in English, Japanese and other languages like Mandarin Chinese, Spanish, and German. He is proficient in Japanese to English translation and checking.
Areas of expertise Biochemistry, biostatistics, genetics, histopathology, pharmaceutical research
Highlights - Japanese-Language Proficiency N1 Level Certification, 2010
- Contact Partnership Scholarship Recipient, University of California, Education Abroad Program
- Awarded Dean’s Honor List
Years of experience 5+
Country Japan
Education and Training MD Rush Medical College, Chicago, Illinois, US
BA Molecular and Cell Biology, Genetics and Development, University of California, California, US
Medicine Resident, Fox Valley Family Medicine Residency Program, University of Wisconsin School of Medicine and Public Health, Appleton, US
Graduate Diploma, Biochemistry, University of California Education Abroad Program, University of California, California, US
Work experience Drug Safety Consultant, Brand Institute, Miami, Florida
- Ensured that drugs met regulatory standards set forth by the FDA, the European Medicines Agency, Health Canada, and the Ministry of Health, Labour and Welfare in Japan.
- Provided medication error prevention analysis associated with the labeling of pharmaceuticals, biological products, and medical devices.
- Performed in-depth analysis of issues related to prescribing and dispensing, including consulting on all aspects of drug information, from profile to packaging to trade-dress.
- Coded in Visual Basic, a screening tool that evaluates Katakana drug names for scripted similarities with existing drug names as per Japanese regulatory requirements.

Bio-technician, Bayer HealthCare, Berkeley, California
- Involved in managing constant perfusion fermentation and cell separation systems, operating and troubleshooting ultrafiltration technology and sampling for quality control

Production Technologist, Bayer HealthCare, Berkeley, California
- Played leadership roles in environmental safety, Six Sigma, and CIP (Continuous Improvement Process) projects
Translator T630
Translator T630
  • This translator has had a long and illustrious career. She has more than 10 years of experience as a consultant to various hospitals and healthcare facilities across Asia in addition to more than 5 years of experience in echocardiographic examination. She is a Japanese native and currently resides in South Africa.
Areas of expertise Cardiology, Cardiac/Cardiovascular Surgery, Molecular Biology, Hypertension, Anatomy, and Biology
Years of experience 10
Country South Africa
Education and Training Postgraduate Diploma in Public Health, Fiji School of Medicine, Suva, Fiji
Certification, Capacity Enhancement Training of Health and
Development, Japan International Cooperation Agency (JICA), Japan
License of Medical Sonographer in Cardiology by the Japan Society of Ultrasonics in Medicine, Japan
License of Clinical Laboratory Technician by Ministry of Health, Japan
Training on Abdominal Ultrasound at National Cancer Center, Tokyo, Japan
Bachelor of Economics, Saitama University, Saitama, Japan
Research and Publication Contributed to “Compact Atlas of Echocardiography” (in Japanese)
“Measurement Accuracy of Mitral Valve Area by Ultrasound Examination”, Japanese Journal of Medical Ultrasound Technology, in Japanese
Wrote a thesis on “Characteristics of Social Figures and Economic Development in the Kingdom of Tonga”
Other Work Experience Consultant of Japan’s ODA health projects and private hospital improvement projects
Medical Sonographer and Clinical Laboratory Technician at hospitals in Japan
Medical Sonographer at Hospital in Kingdom of Tonga
Assistant of Biochemistry Laboratory of Medical University in Japan
Editor PS12
Translator PT29
  • This translator is a Pharm.D. in Pharmacy and Biochemistry from University of Sao Paulo and has more than 10 years of translation experience. He is a member of the Society for Clinical Data Management and is currently a Clinical Data Quality Manager at Bristol-Myers Squibb, Brazil. He has advanced knowledge of clinical operations, data management, budget and contracts, SAE/eSAE processing, management and monitoring of clinical trials, onsite monitoring, vendor management, Phase IIV clinical development, post-marketing trials, regulatory compliance, clinical pharmacology, medical writing, drug supply, and IVRS processes.
Areas of expertise Pharmaceutical research, Pharmaceutical chemistry, Pharmacotherapy, Cancer research, Food microbiology, Molecular biology, Histopathology, Nucleic acid research, Metabolism, General biochemistry, Dermatology, Cardiology, Endocrinology/Ophthalmology, Gastroenterology, Hepatology, Immunology, Infectious Diseases (HBV, HCV, HIV), Neurology, Oncology/Immuno-Oncology, Ophthalmology
Years of experience 10
Country Brazil
Education and Training Doctor of Pharmacy (Pharm.D.), Pharmacy and Biochemistry, Universidade de São Paulo, São Paulo, SP, Brazil
Data Management for Clinical Research, Vanderbilt University, USA
Work experience Clinical Data Quality Manager, Bristol-Myers Squibb Company, Brazil
- Manage the data collected from 12 clinical trials distributed among 63 clinical sites in Brazil plus 6 clinical trials conducted in Canada.
- Revision of quality metrics and data trends.
- Performance of clinical listing review per Data Review Plan.
- Site support on Serious Adverse Event reporting and follow-up.
- Support sites with account registration for company’s systems.
- Training/coaching on CRF/eCRF completion.
- Data cleaning, eCRF application (coordination of Data Early Process Control and Ongoing Data Quality Control activities).
- Provision of ongoing feedback on Oracle Clinical system validations/eCRF instructions and escalation of any data issues to upper managers.

Clinical Research Associate, PPD do Brasil Suporte à Pesquisa Clínica / PPD Intl, Brazil
- Phase II/III Diabetic Macular Edema (DME) trial
- Phase I Anticonvulsant Therapy trial
- Phase III Lupus Nephritis trial
- Phase II Respiratory Syncytial Virus (RSV) trial

Jr. Clinical Research Associate, AAIPharma/IPCSP, Brazil
- Elaboration of clinical trial protocol, Informed Consent Forms (ICF) and Case Report Forms (CRF).
- Translation of protocols, ICF, paper CRFs and trial-related manuals and contracts.
- Electronic CRF training; certified e-CRF trainer Site Initiation Visits and Interim Monitoring Visits (IMV), monitoring reports, management and report of Serious Adverse Events, regulatory management, import and distribution of investigational products to sites, export of biological samples to central laboratories, clinical data management, organization and leadership of an Investigators’ Meeting.
- Development and improvement of management tools for internal administration, monitoring visits and clinical trials.
- Creation of electronic CRF, electronic monitoring forms, electronic SAE report form and electronic monitoring expenses report form (incorporated to the company’s portfolio and SOP).

Translation Technical Manager, R A Serviços de Traduções Médicas e Científicas Ltda, Brazil
- Translation of Clinical Trial Protocols, Investigator’s Brochures, Safety Reports, Regulatory Letters and Documents, Case Report Forms, Informed Consent Forms, Academic Articles.
- Management, training and follow-up of a team of 192 translators.
- Management of the company and assignment of duties to employees.
Translator TW158
  • He is a translator specializing in Homeopathy, Naturopathy, Nutritional-based Therapies, Health Information Manage-ment, Healthcare,Economics, Hospital Management, Public Health Management, Allergology, History of Medicine, Pulmonology Medicine, Family Nursing, Geriatric Nursing, and more. Heobtained his pharmacy degree from the Kaohsiung Medical University in Taiwan. He also has a Master’s degree from the Texas State University. His work expertise reaches close to 30 years in translating.
Areas of expertise Homeopathy, Naturopathy, Nutritional-based Therapies, Health Information Management, Healthcare, Poli-cies/Economics, Hospital Management/Administration, Public Health Management/Administration, Allergology, History of Medicine, Pulmonology/Respiratory Medicine, Family Nursing, Geriatric Nursing, Home Health Nursing, Family Planning, Pharmaceutical Toxicology, Pharmacodynamics, Pharmacokinetics, Pharmacotherapy
Years of experience 30
Country Taiwan
Education Department of Pharmacy, Kaohsiung Medical University, Taiwan
MBA, Texas State University, United States
Professional Training and Certification Pharmacist certificate
Work experience District sales manager of Pfizer Pharmaceutical Company
Product manager, Schering-Plough Pharmaceutical Company
OTC marketing manager, Sandoz Pharmaceutical Company
Phamaceutical markeing manager, Novartis International AG
Research and Publication experience Miller & Spoolman:Environmental Science 13/E
Skills Chinese to English Translation