We are a pharmaceutical company locate in Brazil, that develops and manufactures complex sterile injectable drugs with higher quality.

Our team is highly qualified, our factories and laboratories are new and modern, all governed by a quality system designed to meet the highest requirements of international regulatory agencies (FDA, EMA, ANVISA).

Our History

Following the NC Group's internationalization plan, RBBL emerged as a spin-off in 2021, to be a fully operational pharmaceutical industry. The NC Group's internationalization project began in 2017, with the founding in the US of Rio Biopharmaceuticals INC - RBI (https://riobiopharma.com/). An RBI operates on a portfolio strategy and has all the technical knowledge to register and market complex pharmaceutical products in the US market. RBBL was created to be a manufacturing unit that supports the research and development and production of commercial batches for RBI and other international companies of the NC Group, such as Galenika and Germed Portugal, in addition to producing commercial batches for the Brazilian market. RBI and RBBL work together to continuously build technical skills that, together with more than 50 years of experience in the production of medicines for the NC Group, allow us to produce high quality medicines.

These knowhow was fundamental to create RBBL, a pharmaceutical company focused on producing complex injectable products in devices, and will work as the commercial facility for RioBiopharmaceuticals INC US.

NC Group

NC's Group experience in making medicines of all pharmaceutical forms and marketing in Brazil and exporting to more than 20 countries gave us the necessary subsidies to create a new pharmaceutical (RBBL) company dedicated to the manufacture of complex sterile injectable products.

RBBL (A NC Group Company) emerged during the national and international market's need for specific and technological products focused (Drug Devices Combinations) on improving human health. For this purpose, RBBL has specialized professionals to meet the strictest international quality controls.

Mission

Make complex injectable drugs and innovative drugs available to the market, seeking to expand access and meet unmet medical needs. Always working with the highest standards of quality and integrity, meeting the expectations of international regulatory agencies.

Vision

Become a company that turns ideas into reality through the development of formulations to the production of new products on state-of-the-art technology platforms. In this way, we transform the lives of patients, bringing well-being and improving their quality of life.

Values

Integrity
Training and recognition of professional
Commitment to Quality
Innovation
Excellence

Operations

The operations team leads the entire production, maintenance, weighing and engineering team in delivering the area with quality and excellence, always in tune with the other teams. We work in a sterile factory with products that will be exported to FDA and EMA, which requires a robust and traceable process, with a high quality index.

Project Team

The project team works in synergy with the teams, developing robust schedules and monitoring the development and execution of the project portfolio, ensuring that deliveries are made in accordance with the company's purpose.

Our team has different expertise to meet the most diverse technical ways and needs to lead time with robust deliveries and excellence throughout the product cycle, from the research and development stages to the commercial product. We are based on solid, clear project management based on linear communication between teams.

Physical-Chemical and Microbiological Quality Control

Responsible for the physical-chemical and microbiological quality control laboratories at RBBL. Working with the team in the development and validation of analytical and microbiological methods for high added value sterile injectable products.

Following all FDA, 21 CFR part 11 and ICH recommendations, we have a complete and traceable flow for international submissions. Supporting the development of new formulations and interacting directly with the production team with the necessary synergism for the best optimization of projects.

Regulatory Affairs

RBBL understands the regulatory area based on concepts of Intelligence and efficiency. The focus on regulatory intelligence helps RBBL anticipate and manage global regulatory developments by tracking multiple sources of regulatory information.

RBBL's regulatory process includes monitoring, collecting and analyzing publicly available and experience-based regulatory information to develop a strategy for cost-effective and time-efficient drug development. RBBL's Regulatory Intelligence is reactive and comprises the synthesis of information into objective actions that aim to ensure the company's success. Our regulatory intelligence flow process can be summarized as an information capture, analysis process and formulation of a regulatory strategy:

Finally, knowing which products are under development, which of those products are successful and which have been approved is important to our own development process. Assessing what the risks of our products are, knowing why others failed or were approved later than expected, it may also be of specific interest for RBBL to identify potential regulatory obstacles early in development and apply this information to improve the likelihood of success of our development program.

Knowledge of new regulatory requirements, specific trends and interpretation of global requirements is critical to our development and creation of creative and innovative regulatory strategies to obtain and maintain product approvals in a timely and efficient manner.

Quality Assurance

Our mission is to deliver quality, and for that, we carry out our work not only with responsibility and excellence, but also with passion. Our solid foundation is built on in-depth knowledge based on requirements and standards, and allows us to maintain a culture of quality rooted in all our processes, meeting the highest regulatory requirements.

Our commitment is to people and our focus is on a better future, with better quality of life and longevity. We have technology, integrity, agility as allies, as well as our determination and commitment, we always do our best!

I'm part of Rio Biofarma Brasil's quality assurance, and I'm proud of what I do!"