Regulatory Assistance

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NerPharMa Srl. offers a wide range of services which includes regulatory assistance. Features: it offers to national and international partners, guidance and consulting in dossier preparation and filing. With particular experience in CMC section support for IND, NDA filings (EU, US, Japan); post filing/post marketing support.
NerPharMa srlNerPharMa is a CDMO with a strong specialization in Oncology on NCEs, innovative formulations and new technologies. With two different departments: NerPharMa DP dealing with the development and manufacturing of compounds, injectables and solid oral for various therapeutic areas, packaging and distribution; NerPharMa DS dealing with the development and production of active principles only oncological from laboratory scale to commercial products.

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