Ispharm CRO

Ispharm s.r.l.

Via Dorati, 117 55100 LUCCA

Tel / Fax + 39 0583 56899

Services -

Registration Procedures

ISPharm owns a particularly interesting sector, which is institutionally oriented to the management of problems related to drug legislation and to relations with the Regulatory Authorities.

consultancy on drug registration and revision ;
consultancy on the preparation and presentation of official reports to the Regulatory Authority;
Final Reports processing;
writing up of Expert Reports (technical, pharmacotoxicological and clinical expertises) which is carried out by experts selected by CRO or indicated by the customer; in conformity with the current requirements;
contacts with the Regulatory Authorities;
follow-up of ministerial papers;
Submission of Marketing Authorisations renewals, including reports on number and severity of adverse reactions related or possibly related with the use of the medicinal product (Phase IV clinical trials included), in accordance with the format and content required by the Note for Guidance on Clinical Safety Data Management : Periodic Safety Update Report for Marketed Drugs (CPMP/ICH/288/95), completed by appropriate scientific assessment.