The pharmaceutical translation is required at many stages, including clinical research, regulatory submission and review, production, and marketing. Accurate pharmaceutical translation services mainly help drug companies grow pharmaceutical sales internationally, extend sales in the United States, or across the European Union's member states. Professional language services provided by MedTrans can help pharmaceutical companies bring a drug to market faster than before. Our translation and expert team can also help streamline the clinical trial process. Our quality policy is compliant with the ISO 17100:2015 standard. It was prepared by the International Organization for Standardization's Technical Committee ISO/TC 37, Terminology and other language and content resources, Subcommittee SC 5, Translation, interpreting and related technology. It includes provisions for translation service providers (TSPs) concerning the management of core processes, minimum qualification requirements, the availability and management of resources, and other actions necessary to deliver a quality translation service.
Drug Development Plan
Drug development is a costly, lengthy, laborious and usually, sequential process. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the pre-clinical lead compound stage through Lifecycle Management (LCM).
- BLA/NDA (first Marketing Authorization) Approval
- Discovery Phase
- Non-Clinical & Pre-Clinical Development
- IND Submission
- Clinical Development Phases
- NDA/BLA Submission
Featured Translation Services
Summary of Product Characteristics (SmPC)
(Related requirements and regulations: )United States Prescribing Information (USPI)
Linguistic Review and Validation
Linguistic Quality Assurance (QA)
Linguistic Quality Assurance (QA)
An increasing number of clinical research and drug manufacturing is conducted in multiple countries with multiple languages. MedTrans has specialized, in-country medical translators in all member states that provide linguistic review and validation. We are familiar with the QRD (Quality Review of Documents) process and can deliver translations that are accepted with minimum revision requests. We can also provide linguistic QA prior to any pharmaceutical process.