Technical Translation
Translation from and into another language is a complex endeavor and can be very challenging. You must know the peculiarities of both languages, as each language has its own built.
Our validation engineers at Stolley Engineering, who are well-qualified, have an understanding of pharmaceutical science and manufacturing processes related to biopharmaceuticals and immunotherapies, allowing us to provide technical translations services on a broad scale.
Our Translation Services
- Marketing Authorization Application (MAA)
- Common Technical Document (CTD)
- Clinical Trial Regulation (CTR)
- Biologics License Application (BLAs)
- Medical Device Registration (MDR)
- Invitro Diagnostic Regulation (IVDR)
- New Drug Approvals (NDA)
- Drug Master File (FDA 21CFR Part §314.420)
Translation Services for Regulatory Submission
Our company offers translation services for regulatory submission and oversight throughout the entire technical documentation. We are leveraging our GMP expertise and qualifications to ensure reliable documentation.
Translation Services for GMP Documentation
- DQ, IQ, OQ, PQ
- Risk Assessment
- URS
- Validation Plan
- Qualification Plan
- SOPs and Master SOPs
- Reports and Final Reports
- Validation Master Plan (VMP)
- Qualification Master Plan (QMP)
- Site Master File