LARJ is synonymous with results in regulatory affairs in the pharmaceutical area and in innovative chemical technology.
ABOUT US
LARJ CONSULTORES ASSOCIADOS
LARJ Consultores Associados was established in August 2000, led by Rosely Baroni Jermolovicius, with a focus on services in regulatory affairs, given its experience in regulatory affairs at global companies such as Merck Sharp & Dohme and Procter & Gamble, as well as a Brazilian company. Rosely holds Master’s degree in drug planning, a Bachelor degree in Pharmacy and Biochemistry and Bachelor of Law, from the University of São Paulo, and Lawyer. She has worked with several therapeutic classes and being a strategic partner in solving customer problems. From rare diseases (orphan drugs), biologic, oncology medicines to cannabis products, new and generic products, as well as the full range of innovation and regulatory particularities are the target of customized activities for each client, focusing on success with Anvisa.
In 2021, Luiz Alberto Jermolovicius joined the consultancy creating the service area for the chemical processing industry. He served as R&D Manager at Elekeiroz. He holds Doctorate and Master degrees in Chemical Engineering, both from the Polytechnic School of the University of São Paulo, with emphasis on calculation of reactors. Chemical Engineer at the Maua School of Engineering, Brazil – São Paulo, where he retired as main professor. Develops flow chemistry and microwave applications to industrial processes. It has published scientific articles and registered patents in Brazil and abroad. With strong academic background and experience in chemical and pharmaceutical industry, collaborates on innovation in the chemical processing industries, covering from the state of the art analysis, statistical planning of experiments for process development and optimization, to studies of scale up and economic feasibility analysis.
Company headquarters, in São Caetano do Sul, SP
Why LARJ?
Because we have experience, credibility and results that prove the benefits gained from this consultancy, by our clients.
Because we have partner experts who provide to meet in specific details in our proposals.
LARJ is synonymous with good results.
OUR TEAM
Professionals who lead LARJ Consultores:
Rosely V. Baroni Jermolovicius
Luiz Alberto Jermolovicius
OUR SERVICES
LARJ operates on two major fronts:
Regulatory Affairs area
Regulatory maintenance of portfolios of inactive products of companies in Anvisa (life cycle)
Preparation of technical documents to meet post-registration standards (PATE, leaflets, changes, etc.)
Information on Brazilian legislation and regulatory scenario for foreign companies
Regulatory due diligences – involves systematic review of the regulatory compliance status of an organization and its suppliers, agents and partners
Chemical technology area
Consultancy for research, development, and innovation (RDI) in chemical processing industries
Consultancy for the implementation of ecologically friendlier processes (green chemistry) and flow chemistry
Consultancy for the optimization of industrial processes
Aplicação industrial de micro-ondas
Statistical planning of experiments applied to industrial processes
Processes for waste chemical recycling
CONSIDER THE FOLLOWING
What is critical to find in a consultancy for 'regulatory affairs'?
MULTIDISCIPLINARY TEAM - COMPETENCE
A team of professional graduates from different areas, working in synergy, offering a quality consultancy
EXPERT KNOWLEDGE
Given regulatory complexities, no company has extensive knowledge and experience in all areas. You should seek a partner who meets your needs and requirements in a specific way
CONFIDENTIALITY - TRUST - TRANSPARENCY
Commitment – there are numerous critical and legal issues of the relationship between companies and the public sector, and this cannot be a deterrent. Trust is key to performing the best work
'BIG PICTURE VIEW' - BUSINESS CULTURE
You’ll need a partner with a broad understanding of business and legislation to help you drive your regulatory strategy to reduce costs and increase efficiency while maintaining the quality and compliance of your products
CONSIDER THE FOLLOWING
What is crucial to find in a consultancy for 'chemical technology area'?
UPDATING TECHNOLOGICAL KNOWLEDGE
Expertise in patent search and their analysis, also in scientific articles to prepare of conceptual design of chemical process and its respective incipient economic viability evaluation. Comparison between synthesis routes
EXPERIENCE IN PROCESS DEVELOPMENT AND OPTIMIZATION
Analysis of the chemical reactions involved in the process generating an evaluation of the reaction conditions and formation of by-products. Planning of experimental activities in laboratory and pilot plan scales, for processes and unit operations. Catalyst selection. Experimental determination of complete chemical kinetic equation. Experimental design. Mass and energy balances. Economic feasibility and scale up studies
KNOWLEDGE OF STATISTICS APPLIED TO DESIGN OF EXPERIMENTS (DOE)
Selection of independent process variables according to their effects intensity and its significance. Exploratory and modeling (linear, multilinear, and quadratic) experimental designs of processes. Design for process optimization
PROCESS INTENSIFICATION AND DISRUPTIVE INNOVATION
Application of microwaves to chemical reactions (microwave chemistry) of low temperature (up to 500 °C) and high temperatures (above 500 °C). Application of microwaves to unit operations (drying, extraction, microwave-assisted distillation). Application of new chemical processing concepts for process intensification. Batch process transformation for flow chemistry processes
ORIENTATION OF DEVELOPMENT TEAMS
Monitoring of teams in process development and optimization activities, guiding their activities to the best possible results
Can we help you?
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LARJ Consultores Associados Ltda.
Alameda Terracota, 215 – 5º andar – Cj. 518 – Union Park Espaço Cerâmica
CEP 09531-190 – São Caetano do Sul – SP -Brazil
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