CMC stands for Chemistry, Manufacturing and Controls. The process in which drugs are evaluated with regard to their specific qualifications is called CMC documentation. It defines not only the manufacturing process itself but also the quality control release testing, specifications and stability of the product together with the manufacturing facility and all of its support utilities, including their design, qualification, operation and maintenance. All submitted regulatory documents require CMC data, such as Investigational New Drug Application (IND), Chemical and Technical Assessment (CTA), Marketing Authorisation Applications (MAA), New Drug Application (NDA), and Annual report. Sufficient detail must be provided so that the agency reviewers can understand and evaluate the process. European agencies in particular require a significant amount of information on raw materials of animal origin and on their use in the process, as well as in the preparation of master seeds or cell banks.
CMC Documentation Translation
CMC documentation related content must be prepared and translated by medical experts to avoid critical mistakes. Translating such content requires extensive pharmaceutical terminology and therefore should be only handled by expert CMC documentation translators. They are well aware of the pharmaceutical legislation and can produce high-quality translations. Our proofreading team will then check CMC documentation translations in terms of terminology, grammar and format.
MedTrans professional translation company offers excellent CMC documentation translation services and lets you translate CMC documentation related content in the desired languages which include Portuguese, French, German, Spanish, English, Arabic and Russian.
- Fast Translation
- Expert Pharma Translators
- Dedicated Proofreading Team
Strict Confidentiality Mechanism
- Strictly protect the documents and information delivered by customers from being leaked.
- Sign confidentiality agreements with the customer and all the responsible personnel.
It mostly depends on the language pair and total word count. Overall, it’s quite cost-effective.
MedTrans has many clients who rely on its services when they need to translate CMC related text and documents. We are exceptionally well-equipped to serve you. Get a quote from the first-class CMC documentation translation firm.
- Clinical Trial Translations
- Regulatory Translation
- Medical Device Translation
- Patent Translation
- Pharmaceutical Translation
- Medical Writing
- Medical Publishing Translation
- Medical Website Translation