OP Pharma Srl

About OP Pharma Srl

IT/EU REGULATORY AFFAIRS
OP Pharma has been providing innovative&customized services in the Regulatory Affairs field for 20+ yrs to small and big pharma Companies in the EU, ranging from:
-PRACTICES: submission and follow up of registration,variation,price,PI,advertising,CEP/DMF,plant practice,etc
to
-TECHNICAL DOCUMENTATION: lifecycle management,due diligence,deficiency, technical translation,eCTD compliance,etc
By means of self-developed IT tools we are also able to manage dossiers & RA data from hundreds of products.

PHARMACEUTICAL PRODUCTS
OP Pharma was able to develop and register innovative pharmaceutical products having pluses over competitors:
- 1999: first w.wide to register topical Diclofenac 4%
- 2007: first in IT to register Dexibuprofen
- 2014: first in IT to register generic liquid Vit D3
- 2019: registered liquid Vit D3 in 5 EU Countries.
We look for local partners w.wide for promotion and distribution of our products on the basis of win-win relationships.

  • 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
Contact info

Products from OP Pharma Srl (5)

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

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

    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 DM...
  • 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 of ...
  • 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 of t...
  • 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 upda...