Pharmaceutical documents, IFU’s and Package Inserts

As life sciences companies expand their presence globally, a wide range of documents such instructions for use (IFU) and package inserts must be accurately localized to ensure compliance with international regulations and rules. CSOFT appreciates that companies in the pharmaceutical, medical devices, and biotech industries are bound by strict regulations for their IFU labeling and these regulations can further differ from country to country. However, because of the nature of the industry, the burden of “zero defect” for packaging and labeling remains paramount. At CSOFT we work closely with you to understand your particular requirements and ensure that the finished product packaging and IFU labeling conforms to local regulations precisely.

CSOFT utilizes not only our knowledge about the life science industry, but also our years of experience localizing for large global enterprises, to focus on technology and process driven solutions that eliminate the human error factor.

CSOFT has experience with the following type of IFU localization

EU Enlargement and Multilingual Labels and IFU's
Country and Market Specific Destination Labeling
Label Life Cycle Management/Version Control
Structured Product Labeling (SPL) Compliance
Compliance with FDA 21 CFR Part 11 & Part 820
Structured Product Labeling (SPL) Compliance
Validation Services and Risk mitigation

Knowing the requirements for the country you will be selling to is crucial. For instance, the European Union (EU) has two key compliance requirements that are necessary before receiving the CE mark. Companies must translate all packaging and IFU materials into the national language if the product will be offered for sale within the EU. Some companies are currently exploring the option of e-Labeling as a cost saving option directing consumers to the translated versions of their IFU on the company’s website. However, this should be approached with caution as the regulations around IFU labeling vary from country to country and from product to product. Frequently drugs and medical devices will face strict requirements for hardcopies of the localized IFU to be accompanying the product. Many countries such as Croatia, Czech Republic, Japan, Netherlands, China, Romania, Taiwan, and as previously mentioned all countries within the EU, require hardcopies of the translated IFU to be provided. We will always work with you to tailor a solution to meet your specific localization requirements.