At Polpharma B2B we offer custom development and manufacturing services for clients looking for a European manufacturing site for their active substances.
With broad experience in complex chemistries, dedicated project management and R&D team, corporate quality system and service excellence, we deliver tailored solutions to meet your every need.
Our multipurpose API plant passed FDA inspections with no observations on the Form 483 in 2004, 2009, 2012 and most recently in January 2015.
We have a successful track record in Technology Transfer development and commercialization in regulated markets. We are focused on Projects from Phase IIa CTM's onwards.
We offer top class regulatory support for product registration process in the most demanding of markets - US, Europe, Japan, Korea, Brazil and many others.
Professional project management team coordinates for you all project activities performed by the R&D, RA, QA and other Operational departments of Polpharma. All of this with the sole purpose of you maintaining a full control over your product.