REGULATORY AFFAIRS

A significant track record built over the years in dialogue with European and American Regulatory Authorities enables us to provide support services for your projects, including advising and preparing dossiers. MolMed GMP Solutions performs regulatory evaluations with the top standards, with a dedicate team of experts in worldwide regulatory guidelines required for biological products. Our support includes:

• Contacts with National and International Regulatory Authorities.

• Advice on regulatory and product development plans and strategies.

• Advice on  regulatory legislation during all stages of product development.

• Assistance in the Scientific Advice process with National and International Agencies (EMEA, ISS / AIFA, MHRA, AFSSAPS, BfArM / PEI).

• Preparation of documentation and administrative assistance for FDA Pre-IND and End of Phase II meetings.

• Preparation of documentation and administrative assistance for Orphan Drug Designation requests in Europe and United States.

• Preparation, review and submission of clinical trial application in CTD format at European Regulatory Authorities (IMPD and IB) and to the FDA.

• Reformatting of documents to CTD format.

MolMed S.p.A. - via Olgettina, 58 – 20132 Milan (Italy) – Tax identification number: 11887610159 – Capital stock at 05/08/2010: € 43,572,874.14 fully paid - Milan Company Registry nr. 11887610159