OP Pharma

Regulatory Affairs Outsourcing and Consulting

Young and dynamic society

Dr. Osvaldo Ponchiroli

Performance, Services, Digital Regulatory

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Through its regulatory and PoA services, OP Pharma is able to carry out all the activities accompanying the business of the customer.

Regulatory Affairs is a sector in which the bureaucratic aspects (especially in Italy reality) have a relevant importance in the total of the planned activities:

From the management of a heavy and varied product portfolio based on marketing directives and in an evolving regulations environment, passing through relations with the authorities up to the document preparation and updating of the texts.

These are the aspects that, because of their specificity and diversity, disperse time and skills internally.

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.

Archiving data and documentation is a repetitive and ancillary activity, but allows quickly finding information and getting an overview of all the products in every single aspect, increasing internal productivity and saving time.

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