Regulatory Affairs

A significant track record built over the years through liaison with European and American Regulatory Authorities enables us to provide support services for your projects, including advisory services and dossier preparation.

MolMed GMP Solutions performs regulatory assessments with a dedicated team of experts in worldwide regulatory guidelines on biological products. Our support includes contact with national and international regulatory authorities, advice on development plans and strategies, and regulatory advice during all product development stages.

Moreover MolMed GMP Solutions can provide assistance in the Scientific Advice process with national and international agencies (such as EMA, ISS/AIFA, MHRA, AFSSAPS, BfArM/PEI) as well as in the preparation of documentation and administrative assistance for FDA Pre-IND and end of Phase II meetings, and the preparation of administrative documentation for Orphan Drug Designation applications in Europe and United States.

MolMed GMP Solutions also offers expert support in the preparation, review and submission of clinical trial applications in CTD format to European Regulatory Authorities (IMPD and IB) and to the FDA and reformatting of documents to CTD format.

MolMed S.p.A. Via Olgettina, 58 - 20132 Milano, Italy | Phone +39 0221277.1 - Fax +39 02 21277.325 | -
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Share capital € 21,819,020.83 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159