Balkonnect Festival 2025 - B2B Matchmaking Event

23–24 May 2025 | Prishtina, Kosovo

O.P. Pharma Srl

Company

www.op-pharma.it/Milan, Italy
2 profile visits

About

Located in Milan (Italy) and inspired by its international attitude, OP PHARMA is either an highly experienced CRO specialized in IT/EU Regulatory Affairs, as well as owner of self-developed, value-added and innovative pharmaceutical products aimed to develop its business worldwide.

PHARMACEUTICAL PRODUCTS

Thanks to the collaborations held with national and international partners, OP Pharma was able since the beginning to develop and register, in Italy and then at EU and international level, innovative pharmaceutical products boasting well-documented pluses over competitors:

- in 1999 was the first company to register topical Diclofenac 4% spray worldwide;

- in 2007 developed and registered Dexibuprofen tablets and granulates in Italy;

- in 2014 developed and registered the first generic Cholecalciferol liquid formulations in Italy;

- in 2019 registered Cholecalciferol liquid formulations at EU level in 5 Countries including IT, DE, EL, ES and PT.

Always interested in developing value-added pharmaceutical products and to develop its business worldwide, OP Pharma is available for discussing new opportunities to out-license its products with local distributors on the basis of win-win business relationships.

REGULATORY AFFAIRS

OP Pharma has been providing all-around, innovative and customized services and support in the Regulatory Affairs field of pharmaceutical products for more than 20 years from small to big pharma Companies in Italy as well as in the European Union. Our expertise ranges from:

- PRACTICES: submission and follow up of registrations, variations, prices, texts, renewals, advertising material, CEPs and DMFs, manufacturing plants practices, etc... to:

- TECHNICAL DOCUMENTATION: lifecycle management, digitization of paper documents, due diligences, documentation drafting, answering to deficiency letters, technical translations, eCTD management and compliance, etc...

By means of self-developed IT tools we are also able to manage dossiers and RA data from hundreds of products and thousands of packs, at national, EU and FDA level.

SECTOR

ManufacturingOutsourcing Services

Representatives

Federico Ponchiroli

Product manager

O.P. Pharma Srl