Drug Manufacturing

Many of our pharmaceutical clients work with contract manufacturers (CMOs) in Europe and Asia, which can pose a challenge for US-based QA personnel. How to decipher all the deviation reports, production reports, and technical analysis documents delivered in German, Italian, French, and Japanese?

We work with both editable documents and static scans, re-creating form templates through OCR conversion to cut time and costs. If the CMO sends an executed form, we can translate and enter all handwritten entries and marginal comments. For updated versions of already-translated documents, we will retrieve prior translations from our archives and revise them to match the new version, passing the cost savings to you.

PROJECTS INCLUDE

• Standard operating procedures (SOPs)

• Master batch records (MBRs)

• Deviation reports

• Reports from testing laboratories

• Validation reports