REGULATORY AFFAIRS

• Regularization of the company in Brazil: Authorization for Operation (AFE) and Special Authorization (AE) for pharmacies, distributors, carriers and industries
• Elaboration of checklist and monitoring of Sanitary Permit.
• Certificate of Good Manufacturing Practices (cBPF) with ANVISA: Complete pharmaceutical and legal consultancy in the preparation of documentation and protocol.
• Regulation of regulatory dossier. - Registration of Medicines, Cosmetics and Medical Products in Brazil.
• Electronic Process and Protocolization.
• Administrative measures and preparation of documentation to comply with Requirement.
• DMF analysis: We are specialists in DMF analysis having a multidisciplinary team able to verify and analyze the routes of synthesis, solvents, impurities, polymorphism, deficiencies according to resolution ANVISA agency- RDC 73/2016. We also work through meetings and training in the company, so the company does not outsource the service, but identifies with its own team the gaps that need to be addressed.
• Consulting in company to fill PATE.
• Consultancy to obtain the CE marking for Medical Products.
• Consultancy to obtain the cosmetics register in Europa.