Custom Development

    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.

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    WE ARE EXPERTS IN COMPLEX CHEMISTRIES SUCH AS:

    • Phosphorus, carbohydrate and organometalic chemistry (bisphosphonates,glycosylation, lithium)
    • Chiral, Stereo and radioselective synthesis
    • Large scale Sodium Amide chemistry
    • Catalysis incl. phase transfer
    • Catalytic Hydrogenation in large scale
    • Solid state chemistry

    SUCCESSFUL FDA AUDIT TRACK RECORD

    Our multipurpose API plant passed FDA inspections with no observations on the Form 483 in 2004, 2009, 2012 and most recently in January 2015.

    FROM LAB TO MARKET

    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.

    WORLD CLASS REGULATORY SERVICE

    We offer top class regulatory support for product registration process in the most demanding of markets - US, Europe, Japan, Korea, Brazil and many others.

    YOU HAVE OUR FULL SUPPORT:

    • IP protection and confidentiality
    • Process optimization
    • Analytical method development & validation
    • Process scale-up from lab to pilot plant kg scale and multi-tons synthesis
    • Preparation of comprehensive regulatory documentation in an eCTD format.

    WE GUARANTEE YOUR PEACE OF MIND

    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.

    WE HAVE NETWORK OF PARTNERS IN THE AREAS OF:

    • Industrial scale purification - HPLC, ion- exchange and membrane
    • Aminoacids and Peptide chemistry
    • Biocatalysis
    • Continuous process chemistry