Why outsource?

Regulatory Affairs is a sector that involves a number of different skills: maintenance of a product package, preparation of the documentation, continuous legislative changes, compliance of the QA with the digital information (Data Integrity, Audit Trail) are aspects that require a heavy investment of internal resources. OP Pharma has the in-depth preparation, serious professionalism and respect of punctuality deliveries to be able to perform - on a commission basis - all these ”accessory” activities to your real core business.

We are convinced that the combination of experience in the pharmaceutical and regulatory sector and the technological-IT support with which the company has equipped itself over the years guarantee the fundamental quality of the services our company offers.

The preparation of documents, submission and updating of the procedures until they are concluded are, therefore, the starting points for an integrated service that ensure the maximum transparency, coherence and speed for the clients in accessing their information, rationally processed and organised.

From the standpoint of operations, OP Pharma enjoys proven reliability and guarantees respect of the timing established.

OP PHARMA is a dynamic, young company headed by Dr. Osvaldo Ponchiroli, who has many years’ experience in the sector.

Our staff consists of the following professional personnel:
  • Graduates in Pharmacy or CTF, who manage the Regulatory / Technical / Text Update sectors
  • Experts in charge of managing, preparing and filing documents and information flows
  • Home Made IT and Quality management
  • Expert administrator

Our core business includes:

  • Preparation and maintenance of national, MRP, DC and DCP procedures
  • Preparation and maintenance of variations, renewals, transfers of ownership
  • Translation, preparation and maintenance of the texts of Package Leaflets, SmPC, Labels
  • Price negotiation at AIFA
  • Analyses, conversion, management and maintenance of registrative files in eCTD format
  • Data Entry and Data & Document Management
  • Product development

e-Regulatory

From the part to the whole: e-Regulatory, tracing and analysis.

With its company portal e-Regulatory, OP Pharma offers its clients a privileged overview on the product situation, as well as a detailed review of procedures, products, packs, API, production plants, etc.
Using trend analyses and summary tables of different types, accountabilities and monthly statements, the portal creates the conditions to keep every regulatory and technical aspect of a company’s products under complete control.

SERVICES

Regulatory files

eReg

Consultancy

Technical and Documentary Services

e-DOX