Niculescu Elena Andreea Law Office
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To achive standards requirements

We are available

Let’s know each other:

+40 720.487.916

Qualifications of warehouses , cold rooms and other thermostatic enclosures

Production equipment qualifications

Validate related processes.

Qualification of clean rooms and associated controlled environments

Qualification of systems of utilities ( purified water  , water for injection , clean steam, compressed air , nitrogen )

Computer Systems Validation

Consulting in the elaboration of internal documents regarding the qualification / validation

responsibility

professionalism

seriousness

trust

latest published articles

  • Modificari aduse standardul ISO14644-3, Metode de testare pentru camere curate. Alinierea cu US-FDAOctober 15, 2020
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    where to find us

    • Bucharest, Aleea Luncsoara, 4-6, S2
    • (+40) 720 487 916
    • office@espharm.ro

    let’s know each other

    • Home
    • About us
    • areas of practice
    • Blog
    • Contact
    • Certificates

    Program

    • Monday 9AM - 5PM
    • Tuesday 9AM - 5PM
    • Wednesday 9AM - 5PM
    • Thursday 9AM - 5PM
    • Friday 9AM - 5PM
    • Saturday closed
    • Sunday closed

    useful links

    • National Agency for Medicines and Medical Devices of Romania (ANMDMR)
    • ISPE
    • Interantional Oragnization of Standardization
    • Food and Drug Administration