Good Manufacturing Practice (GMP) Translations
We provide GMP and cGMP translations to help pharmaceutical and medical device manufacturers succeed across languages
Good manufacturing practice (GMP) is essential for the quality production of pharmaceutical products and medical devices, making GMP translations necessary for meeting global manufacturing standards. GMP regulates medical products during production to protect patients from ineffective treatment and adverse events caused by contamination, incorrect labeling, and other manufacturing quality issues. Whether compliant with global practices or certified in a specific market like the U.S. FDA’s current good manufacturing practice (cGMP), GMP translations ensure that all manufacturing quality control measures, from audits and certification visits to everyday production, meet regulatory requirements in any country. CSOFT Health Sciences translates a wide range of GMP documents, including:
- Site master file
- Validation master plan (VMP)
- Quality policy
- Corrective and preventive action (CAPA) SOP
- Change control SOP
- Recall SOP
Our global team of over 10,000 in-country subject matter experts ensures that your GMP translations are understandable across the manufacturing process.
Chemistry, Manufacturing, and Control (CMC) Translations
To help guarantee that new pharmaceutical products are manufactured safely, consistently, and are effective for their intended use, chemistry, manufacturing, and control (CMC) translations enable pharmaceutical companies to provide the necessary paperwork to regulatory bodies and bring new products to international markets. The drug development process is complex, and documenting the manufacturing process, product details, and product testing procedures is a crucial step collectively known as chemical, manufacturing, and control. Following the drug discovery, all aspects of the manufacturing facility and the specifications of the drug product fall under chemical, manufacturing, and power and are submitted as part of clinical trial applications (CTAs) to help establish consistency between the finished product and the product developed within the manufacturing facility. CSOFT Health Sciences specializes in cost-effective and accurate translations for all types of CMC documents.
Learn more about our CMC translations.
Pharmacovigilance Translations
Pharmacovigilance (also known as PhV, PV, and drug safety) is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs), making pharmacovigilance translations a crucial measure to ensuring proper documentation and resolution of such cases. As the global pharmaceutical market shifts overseas, submitting highly accurate translations of standard pharmacovigilance documents like adverse events (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical to protecting consumers worldwide and regulatory approval. With an extensive network of subject-matter experts (SMEs) and native linguists, CSOFT Health Sciences offers highly accurate and timely multilingual pharmacovigilance translation and localization solutions in 250+ languages, from DSURS and discharge reports to CIOMs forms and clinical trial documents.
Learn more about our pharmacovigilance translations.
Biomaterials GMP Translations
Biomaterial translations are critical for life science companies to deliver life-saving biomaterial solutions to patients across languages. Biomaterials are engineered to be biocompatible with the human body and are used clinically in diagnostics or therapeutics. While some biomaterials are passive, many new biomaterial applications are bioactive and interact with the body to enhance the therapeutic value of the biomaterial. Whether a biomaterial is made of metal, polymer, ceramic, or a composite material, accurate translation of regulatory documents, such as during GMP audits and inspections, is required to bring these innovations to patients worldwide. CSOFT Health Sciences provides high-quality translation solutions for life science businesses involved in biomaterials and materials science engineering.
Learn more about our biomaterials translations.
Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.