Jan 26, 2021 19:30
3 yrs ago
13 viewers *
English term

LEC

English to Russian Medical Medical: Pharmaceuticals
Marketing authorization vatiations

Renewal of X (Y) 200 mg injection for Z (страна) plus
Y DS 2nd gen plus DP spec Replacement of internal I 4.65
method with relevant Ph. Eur. 2.9.19 plus updated 32P31 due to
Kalamazoo LEC

Спасибо.

Proposed translations

5 hrs
Selected

изменение (в наименовании) юрид. лица

https://www.ema.europa.eu/en/documents/regulatory-procedural...
3.2.P.3.1 Manufacturer(s) (name, dosage form)
The name, address and responsibility of each manufacturer, including contractors, and each proposed
https://www.pharmatutor.org/content/september-2017/career-fo...
Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database
production site or facility involved in manufacturing and testing should be provided.
Must be extremely organized as LEC projects can run across multiple products/markets.
https://www.sec.gov/Archives/edgar/data/1792044/000119312519...
The Upjohn name traces its history to 1886, when The Upjohn Company was formed in Kalamazoo, Michigan by Dr. William E. Upjohn. Pfizer acquired the brand through its acquisition of Pharmacia Corporation in 2003. The products comprising the Upjohn Business’s portfolio of 20 globally recognized brands are the result of decades of development and strategic investments.
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4 KudoZ points awarded for this answer. Comment: "Благодарю."
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