Maria Caria's Contact Details

Maria Caria's Company Details

Bizaffairs, Unipessoal Lda

Lisboa, Lisboa, Portugal • 6 Employees
Pharmaceuticals

Bizaffairs is a Consulting Company with Senior Consultants that provides support services in the following areas:- Medicines- Health Products (Medical Devices, Cosmetics, Food Supplements and others). Services involved are:- Regulatory & Medical Affairs - CE marking support (Technical File assessement, Risk Management implementation, Clinical Evalution Report according to MEDDEV 2.7.1, rev4, essential requirements support)- ISO 9001:2015, ISO 13485:2016, ISO 22716 implementation and Internal Audits - AIMs new submission and variations management for drug products- Pharmacovigilance, medical devices vigilance and cosmetovigilance support- Clinical trials management and submission to Competent Authorities and Ethics Committees- Cosmetics CPNP notification, PIF assessment and Responsible Person assumption- Commercial Compliance - Waste and WEEE Management support,- TrainingThe company has a personalized service approach to each case and client, in order to better respond to the identified needs, regardless of the type and size of the company.