OP Pharma

Regulatory Affairs Outsourcing and Consulting

Young and dynamic society

Dr. Osvaldo Ponchiroli

Performance, Services, Digital Regulatory

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Regulatory Affairs
Outsourcing and Consulting

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

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Outsourcing

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.

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Web Portal

e-Reg

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…

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e-Dox

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.

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Our Services

Regulatory Practices

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

 

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e-Reg: digital regulatory management

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

 

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Consulting

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

 

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Technical Documentation

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

 

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e-Dox solutions

eCTD Management, Submission and safe Sharing of eCTD sequences.

 

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Outsourcing

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

 

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