IT/EU REGULATORY AFFAIRS - Support and management of Technical documentation and eCTD

IT/EU REGULATORY AFFAIRS - Support and management of Technical documentation and eCTD
Product Description

OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Our expertise covers the lifecycle management of pharmaceutical products, whole or in part, ranging from digitization of paper documents, due diligences, documentation drafting, answering to deficiency letters, technical translations to the eCTD management in any format in compliance with the current regulations at national, EU and FDA level.
We offer customized solutions for the management of dossiers of pharmaceutical products and medical devices, from earliest stages of submission to authorization completion, if needed also by direct interaction with the regulatory Authorities.
We are also able to manage dossiers from hundreds of products and thousands of packs by means of our self-developed IT program e-Dox, to which the customer (as well as manufacturers if needed) can have direct online access from the browser including receiving email alerts.

Do not hesitate to contact us for more information or for a quotation.

See more:
https://www.op-pharma.it/en/technical-documentation/
https://www.op-pharma.it/e-dox/

OP Pharma Srl

  • IT
  • 2021
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Pharmaceutical company
Primary activities
Contract Research Organisation
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Regulatory Affairs

OP Pharma Srl

  • IT
  • 2021
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Pharmaceutical company
Primary activities
Contract Research Organisation
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Regulatory Affairs

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