Audit of compliance regulatory framework for managing changes in products and processes in light of current legislation.
Audit of drug product dossiers and/or processes to verify compliance with the Brazilian legislation.
Preparation and submission of dossier in CTD format
Instruction, conversion, or preparation of dossier in CTD format, including internal training and provision of templates.
Scientific translation of technical documentation or complete dossiers.
Regulatory training for regulatory application and specific guides in the company's practice.
Representation of the international company to ANVISA
Representation of the international company to ANVISA, especially for submission of CADIFA and GMPc.
Prospection and approximation between Pharmaceutical and Pharmacochemical companies in Latin America and Europe.
Ongoing Regulatory Support
Multidisciplinary support for the Pharmaceutical and Pharmacochemical industry’s routine.
Product lifecycle maintenance and management
Assessment and definition of regulatory strategy for drug product lifecycle maintenance and management.
Project management and definition of strategies for optimizing company resources.
Advice on Deficiency Letter Response:
Technical and regulatory evaluation and discussion to define the strategy for Deficiency Letter response.