OP Pharma

Regulatory Affairs Outsourcing and Consulting

Young and dynamic society

Dr. Osvaldo Ponchiroli

Performance, Services, Digital Regulatory

Follow our News Area to stay up to date on the latest news

Copyright OP Pharma 2020

30 annual registrations 230 days for National Phase 20.000 Updated texts 500 Annual variations successfully concluded 1.000 products managed AIC Regulatory Strategy & Legal Basis Procedures National and EU AIC Maintenance Variations, Renewals and PI Texts 2 web dedicated platforms e-Reg On line Data and Doc e-Dox e-CTD lifecycle Management Mail Alert Deadlines and Updates Notifications
Regulatory Affairs
Outsourcing and Consulting

OP PHARMA is a growing company lead by Dr. Ponchiroli’s long experience in the pharmaceutical compart.

Read more about us


Why Outsourcing?

Regulatory Affairs involves several supportive and ancillary activities to the real core business concentration of numerous preparatory activities to the real core business.

Through its regulatory and Power of Attorney services, OP Pharma is able to carry out all these activities on behalf of third parties.

Where can I find the Deficiency Letter of the Variation n°25 of the product? How many Type II variations occurred in that year? Which variation changed the PI?

The combination of the twenty years of experience in the pharma sector enhanced by our full IT integration, allow us to complete our offer with a safe and efficient electronic archive service and products data analysis.

More information

Web Portal


Regulatory Desk: Online procedures, documents, products data and information in one click

OP Pharma, by integrating its consulting and procedures services, offers to its customers the possibility to consult online the products data and the electronic archive of the documentation of its packs through e-Reg, a customized web platform that allows both to find quickly information and documentation, or to get an overview of all the products in every single aspect…

More information


eCTD Management, Submission and Safe Sharing

e-Dox is a web-based system for the management of e-CTD dossiers sequences (previous / subsequent to the base-line) in accordance with the current ICH guidelines.
e-Dox allows to generate documentation ready to be submitted to any regulatory agency that accepts the eCTD format.

The approved documentation is always available for consultation and download by the approved users.

More Information

Our Services

Regulatory Practices

Customer Support, including preparation, sending to the competent authorities and management until the conclusion.


More information

e-Reg: digital regulatory management

Regulatory Desk: on-line procedures, documents, product data and information in one click.


More information


AIFA and Italian Ministry of Health Power Of Attorney: intermediation and problem solving.


More information

Technical Documentation

Due Diligence Project and Solution, dalla conversione alla Base-Line.


More information

e-Dox solutions

eCTD Management, Submission and safe Sharing of eCTD sequences.


More Information


OP Pharma is able to carry out all the RA activities in support of the customer company business….


More information

Work with us
Request more information about our services