Regulatory services

Regulatory services
Product Description

For pharmaceutical products, we offer support for regulatory services such as:
registration via national and European Union procedures;ANDA registration;
drafting of e-CTDs to create e-CTD sequences;
regulatory compliance;
minor and major variations (evaluation and/or management).For medical devices, we offer support for regulatory services such as:
drafting of technical dossiers;
drafting of clinical evaluations;
registration with the Italian Ministry of Health database; 
CE certification for all European Union countries;
Free sale certificate for distribution in non-EU countries.

TUBILUX PHARMA S.p.A.

  • IT
  • 2015
    On CPhI since
  • 4
    Certificates
  • 250 - 499
    Employees

TUBILUX PHARMA S.p.A.

  • IT
  • 2015
    On CPhI since
  • 4
    Certificates
  • 250 - 499
    Employees

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TUBILUX PHARMA S.p.A. resources

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