- Product feasibility study – verification of compliance with standards;
- Drugs’ portfolio analysis;
- Consulting, advisory services and preparation of the dossiers for product registration before ANVISA (new medicines, similar and generic drugs and biological products);
- Consulting and advisory services in preparing and formalizing a registration renewal application;
- Consulting, advisory and preparation of the processes to obtain local license, Federal Authorization and Special Authorization or renewal application;
- Subscription of the company and the technical responsible at the Professional Council;
- Consulting and advisory in sanitary infraction notice proceedings and notices linked to quality deviation;
- Elaboration of administrative defenses;
- Consulting and advisory in the fulfilment of requirements, and the follow-up of registration and post-registration processes;
- Audiences scheduling with ANVISA;
- Assistance in drug recall;
- Technical and legal consultancy;
- Consulting and advisory with the Market Regulation Chamber – CMED;
- Preparation of the international inspection process;
- Pre-inspection in manufacture plants;
- Elaboration of Manual of Good Practices;
- Implementation of Quality System;
- Assistance for Quality Control Lab implementation.