O.P. PHARMA S.R.L.

OP Pharma has provided innovative, customized regulatory affairs services for more than 20 years to small and large pharma companies in the EU, spanning practices such as submission and follow-up of registrations, variations, pricing, product information, advertising, and CEP/DMF and plant practice, as well as technical documentation including lifecycle management, due diligence, deficiency responses, technical translation and eCTD compliance; using self-developed IT tools, the company manages dossiers and regulatory affairs data for hundreds of products. OP Pharma has also developed and registered innovative pharmaceutical products with advantages over competitors, including the first worldwide registration of topical Diclofenac 4% in 1999, the first Italian registration of Dexibuprofen in 2007, the first Italian registration of generic liquid Vitamin D3 in 2014, and registration of liquid Vitamin D3 in 5 EU countries in 2019, and the company seeks local partners worldwide for promoting and distributing its products.