Luca Santi
Global CMC Senior Associate
Pfizer
Italy
Biography
Global CMC Senior Associate at Pfizer - Consultancy activity carried out at Pharmaceutical Multinational Companies; - Regulatory affairs and compliance; - cGXP and ICH guidelines implementation, gap analyses; - Regulatory strategy planning for initial registration, line extension, variation, renewal applications relevant to human medicines and dietary/food supplements in alignment with European, Middle East, American and Asean Regulations; - Common Technical Document maintenance, with focus on Module 3 – Quality and relevant QOS
Research Interest
Regulatory affairs, Research In pharmaceutical sciences