Our Solutions
Knowledge aimed toward results
We develop projects of varying complexity, conveying the necessary proficiency and support through out the execution of all activities.
Strategic Evaluation
- Viability Analysis of veterinary products;
- Regulatory framework;
- Registration of innovation products;
- Evaluation and guidance though all stages of specific product registration;
- "Road-map" of new product registration and product defense.
Audit and Due Dilligence
- Pre-audit to identify risks before official inspections;
- Compliance evaluation related to GMP per MAPA’s standards;
- Regulatory assessment of specific products;
- Portfolio valuation and regulatory exposure analysis;
- Regulatory assistance during company merges, acquisitions, and license
transfers.
Product Registration
- Pharmaceutical and biological product registrations;
- Registry of exempt products;
- Product license transfers;
- Regulatory support to answer requirements;
- Lifecycle management and product changes such as formulation, manufacturing site, label claims.
Establishment Registration
- Company certification with MAPA, manufacturers, importers, distributors;
- Changes or inclusion of Technical Responsible person;
- Support during official visits and inspections;
- Activity extensions;
- Conformity to MAPA’s requirements.
Who We Are
CMJ Consultoria & Assessoria is the result of the expertise of our Partner Cristina Jorge, a Veterinarian with over 20 years of experience in Regulatory Affairs for Veterinary Products who built a solid career through achievements in all stages of product registration.
Cristina started her career preparing submissions processes for Brazil and other countries in Latin America, Asia and Europe, performing all the steps, from initial document evaluation, preparation of technical reports, administrative documents and full dossier assembly according to regulations.
As Export Coordinator, directly interacted with regulatory authorities in several countries in Latin America, such as Argentina, Colombia and Mexico. She was also responsible for the regulatory strategy, leading teams towards the evaluation of different alternatives for each project, considering operational viability, deadlines and definition of milestones.
In the last years within local and international industries, she was responsible for managing Regulatory Affairs and R&D teams, serving as direct contact with Brazilian Regulatory Authorities, thereby establishing excellent communication channels that currently still aid in elucidations needed to ensure precision in our strategy projects.
Adding to her regulatory experience, Cristina is fluent in English and Spanish, having escorted Brazilian authorities during international inspections, as well as participated in meetings with international authorities in different countries accompanying, presenting and translating in these languages.
From this range of abilities and knowledge, CMJ Consultoria & Assessoria was established to offer the best insight, agility and quality within Regulatory Affairs aiding manufacturers, importers, distributors and other companies to achieve their goals related to Animal Health.
With 05 years of existence, our company remais present in the Animal Health business promoting the best regulatory approach towards Veterinary Products, assuring compliance and consistency facing the complexity involved.
Clients and Partners
Contact Us
CMJ Consultoria & Assessoria
E-mail: cristina@cmjconsultoria.com
Contact: +55 19 99858-6880
