Translation Services

We don't get lost in language

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.

Stolley Engineering team is made up of international validation engineers and scientists, who bring a broad variety of experiences and qualifications, allowing us to provide regulatory operation services and technical translations on a global scale.

Our Expertise

  • Proficiency English
  • Sound scientific knowledge in Life Sciences and medical terminology

Regulatory Submission Services

Our company offers regulatory submission support and oversight throughout the entire technical documentation. We are leveraging our  experience and qualifications to ensure smooth documentation.

Please fill out our contact form for further information.

Your Benefits:

  • Reliable and decent documentation

Our Translation Service

  • 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 GMP Documentation

  • VMP and QMP
  • SOPs, Master SOPs
  • URS
  • Risk Analysis
  • Test and Validation Plans, Protocols and Reports
  • Qualification Documentation (DQ, IQ, OQ, PQ)
  • Change Control, Deviation, CAPA