Technical Translation
Our validation engineers at Stolley Engineering, who are bi-lingual, have an understanding of pharmaceutical science and manufacturing processes related to biopharmaceuticals and immunotherapies, allowing us to provide technical translations and scientific writing on a wide range of GMP-related issues.
Translation Services – Medical and Scientific Writing
About Technical Translation
Technical 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.
Translation Services and Scientific Writing
- 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)
Technical Translation Services for Regulatory Submission
Our company offers technical translation services for regulatory submission when applying for manufacturing, clinical trial and marketing authorization with regulatory authorities. We are leveraging our GMP expertise and qualifications to ensure reliably translated documentation.
GMP Documentation and Translation Services
- 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