Bizaffairs, Unipessoal Lda

Bizaffairs, Unipessoal Lda is rated 3 out of 5 in the category pharmaceuticals. Read and write reviews about Bizaffairs, Unipessoal Lda. 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, - Training The 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.