Chemical, Manufacturing, and Control Documents (CMC) Translations

We specialize in supporting life science companies with chemical, manufacturing, and control (CMC) document translations to help ensure the quality and consistency of products during manufacturing.

Home 9 Chemical, Manufacturing, and Control Documents (CMC) Translations

To help guarantee that new pharmaceutical products are manufactured safely, consistently, and are effective for their intended use, chemical, manufacturing, and control (CMC) document 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 clearly documenting the manufacturing process, product details, and product testing procedures is an important step that is 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 control, 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. 

With all types of technical documentation required for the chemical, manufacturing, and control process, including product labels, environmental assessments, product ingredient lists, and regulatory documents, leveraging the support of a language service provider (LSP) is necessary to ensure that any company can safely and efficiently develop new products for global use. CSOFT Health Sciences specializes in cost-effective and accurate translations for all types of chemical, manufacturing, and control documents.

In addition, our global network of linguists and subject matter experts specialize in a full range of localization solutions for documents required in pharmaceutical dossiers, including drug product labeling translations, package information leaflets (PILs) translations, and summary of product characteristics (SmPC) translations. 

Learn more about our full range of translations for dossier documents.  

Clinical Trial Translations for Pharmaceutical Products

Clinical trials are essential for any company developing new pharmaceutical products and ensuring that the quality of the product on the market reflects the quality of the product during clinical trials is a main reason for submitting quality chemical, manufacturing, and control documents. The clinical trial landscape is rapidly evolving to including international trial sites and develop products specific for global markets. To recruit patients for overseas clinical trials and to comply with global regulatory standards, accurate translations for documents needed in all phases of clinical trials are a must have for pharmaceutical companies.

With a global network of 10,000+ translators and subject matter experts, CSOFT Health Sciences specializes in end-to-end clinical trial localizations solutions, including for specific documents like:

Learn more about our clinical trial translations.

Quality Assurance

High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

Learn more about how CSOFT protects companies’ data.

With CSOFT Health Sciences, you can be confident that your client will be happy and that we will deliver you peace of mind.