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...

Read more Show less

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
View company profile
Categories
more categories Show less
Specifications
  • Supplied from
    Italy
More specifications Fewer specifications
Sales Markets
Show more Show less

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
View company profile

More Products from O.P. PHARMA S.R.L. (4)

  • e-Reg: management of Regulatory Affairs' big data

    Product e-Reg: management of Regulatory Affairs' big data

    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.

    Do you have lots of products and/or products' data which you cannot organize/archive interna...
  • IT/EU REGULATORY AFFAIRS - Support and management of Technical documentation and eCTD

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

    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 ...
  • LIQUID VITAMIN D3 (Cholecalciferol)

    Product LIQUID VITAMIN D3 (Cholecalciferol)

    Cholecalciferol is Vitamin D3, which is important for calcium homeostasis and for optimal skeletal health; it acts by (i) increasing the efficiency of calcium absorption from the small intestine and enhancing the absorption of phosphorus from the distal small bowel, which results in proper mineralization o...
  • e-Dox: management of eCTDs

    Product e-Dox: management of eCTDs

    e-Dox: management of eCTDs

    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.

    Do you have dossiers of which you would like to outsource the management and u...