Italy/EU REGULATORY AFFAIRS - Support and management of RA practices

Italy/EU REGULATORY AFFAIRS - Support and management of RA practices
Product Description

Our expertise ranges from submission of registrations, variations, prices, package information texts and renewals (also via CESP), to CEP and DMF submissions (even to FDA), manufacturing plants practices, advertising material...in compliance with the current regulations at national and at EU level.

We offer customized solutions for carrying out administrative procedures and formalities for pharmaceutical products and medical devices, from earliest stages of submission to authorization completion, also as representative by direct interaction with the regulatory Authorities.

We are also able to manage information, data and documents from hundreds of products and thousands of packs by means of our self-developed IT tool e-Reg, to which the customer can have direct online access from the browser.

See more at:
https://www.op-pharma.it/en/regulatory-practices/

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O.P. PHARMA S.R.L.

  • Country/Region:
    Italy
  • Founded:
    1996
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    1 - 24
Company types
Consultancy
Pharmaceutical company
Primary activities
Contract Research Organisation
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Regulatory Affairs
View company profile
Categories
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Specifications
  • Supplied from
    Italy
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Sales Markets
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O.P. PHARMA S.R.L.

  • Country/Region:
    Italy
  • Founded:
    1996
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    1 - 24
Company types
Consultancy
Pharmaceutical company
Primary activities
Contract Research Organisation
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Regulatory Affairs
View company profile

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