Bizaffairs, Unipessoal Lda
Pharmaceuticals - Lisboa, Lisboa, Portugal
Bizaffairs, Unipessoal Lda Employees
Bizaffairs, Unipessoal Lda Details
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.
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