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

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

OP Pharma has been providing all-around 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 ranges from submission of registrations, variations, prices, texts, 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, if needed also 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 program e-Reg, to which the customer can have direct online access from the browser.

Do no...

O.P. PHARMA S.R.L.

  • 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
Specifications

O.P. PHARMA S.R.L.

  • 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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