Services

Regularization of Companies

Manufacturers and national distributors or companies that import health products and their international manufacturers, need to be properly regularized according to their area of activity to be able to market products in Brazil.

• Evaluation of layout and audit in the facilities;
• Obtaining a Sanitary License;
• Obtaining the Operation Permit -AFE (Industries, Importers, Storage and Transporters);
• Alterations (Technical Representative, Legal Representative, Address, Extensions) and License Renewals;
• Alteration of Registration or Company Size at ANVISA;
• Assembly and protocol of processes.

Good Practices

Pre-Inspection for obtaining GMP National and International/GDP

• Evaluation of legal documentation, facilities, manufacturing processes and quality system;
• Guidance for adequacy of possible nonconformities to GMP ANVISA.

Implementation of Quality System documentation

• Best Practices Manual;
• Operational Procedures;
• Technical instructions, records, process validation protocols
  ;
• Trainings

ANVISA Inspection Follow-up

• Daily meetings with company managers to evaluate the inspection process carried out by ANVISA inspectors;
• Assistance in attendance and answers to inspectors’ questions.

Regularization of Products

• Drugs (Biological, Synthetic, Generic, New, Similar, Specific, Clone, Innovative and Radiopharmaceutical)
• Medical Devices (Equipment, Material, Orthopaedic Implant, In Vitro Diagnostics)
• Cosmetics
• Sanitizing
• Food Products (Food Supplements and Probiotics)
• Active Pharmaceutical Ingredients – IFAs
• Due Diligence (evaluation of registration dossiers to identify regulatory gaps);
• Submission of Registration and Post-registration of Products subject to sanitary surveillance
• Elaboration of PATE (Authorized Condition);
• Update/adequacy of package leaflet and labeling.

Brasília Branch Office

Oriens has a branch office in Brasilia, close to ANVISA, for the appropriate referral of the clients’ documents to the Official Bodies. Our service is in-person, agile, safe and effective.

The follow-up of the flow of the protocol, from arrival at Oriens to the protocol, can be done online through our Process Management System (SGP).

• ANVISA Protocol
• Legalizations
• Apostilles
• Consularizations

Training

The current regulatory scenario requires dynamism and constant updates. ANVISA is constantly seeking to reduce barriers and obstacles. The de-bureaucracy, convergence, consistency and harmonization with the global regulatory model are trends that have guided the actions of the Agency and the regulated sector as a consequence.

Oriens, based on its expertise and know-how from its involvement with the most diverse representatives of the sector, offers training in the areas of Quality, Regulatory, Compliance Healthcare and Regulatory Law.

Consult us for custom and in company projects.

Legal

• Defenses, appeals of infraction notices and ANVISA denials;
• Feedback;
• Public Query Contributions;
• Settlement and follow-up of legal proceedings (Writ of mandamus and Preventive Actions, acting in all levels of jurisdiction);
• Advising on advertising of products subject to health surveillance;
• Previews of advertising pieces;
• Dispute resolution of suspension of advertisements.

Compliance Healthcare

The Compliance Program, according to legal terms, is to establish and improve mechanisms for internal controls of companies, with the implementation of codes of business ethics and functional code of conduct, encouraging the development of ethics, integrity and transparency, with mandatory compliance by managers, employees and third parties.

We have a partnership exclusively dedicated to the area of Compliance Healthcare, offering what is most current and technically settled in terms of Good Practices for Compliance Programs for companies operating in the health sector.

• Diagnosis
• Implantation
• Review
• Follow-up/Monitoring