We are a team of 37 professionals, trained in biochemistry, pharmacy, medicine, biology, biotechnology, engineering, communication, innovation management, business administration, foreign trade and systems, that work in an interactive way to develop and market biotechnology products with the highest standards of quality that improve quality of life.
History and Future
Biocientífica SA was founded by Dr. Roberto Sedlinsky with the aim of developing, producing and marketing in Argentina in vitro diagnostic (IVD kits for human diseases. The first products focused on the diagnosis of rare and hard to detect autoinmmune and infectious diseases, as well as the measurement of plasma proteins of clinical interest.
We entered into alliances with leading companies in the United States and Europe to extend a portfolio of high-tech products for human health. We consolidated an export network to distribute our products in Latin America, Europe, Asia and Africa.
Thanks to the progress of the laboratory techniques, since 2002, we launched our molecular biology division. We started the manufacture of kits for molecular diagnosis, originally under an agreement with the French company BioMérieux. Furthermore, we started commercialization of products for isolation and purification of nucleic acids and PCR and Real Time PCR techniques.
From our molecular biology division, we opened new fields of activity: human health, forensic studies, agro-biotechnology (animal health, plants and seeds), soil and food studies.
We created a platform for molecular biology diagnosis, that has been launched in 2020 through the in vitro diagnostic kit Schep SARS-CoV-2 RT-PCR Duo, for the diagnosis of COVID-19. In 2021, we developed Schep SARS-CoV-2 Multi-FAST, in a multiplex fast format.
At present, our R+D department is developing 4 new products for the detection of viral diseases using Real Time PCR. We will continue expanding our presence in Argentina with the incorporation of new offices in different regions of the country. Furthermore, we have entered into alliances with universities and research centers for the development of new products.
Our Goals 2024
Fields of activity
Innovation and Development
We develop in-house new products and enter into strategic alliances with universities and R+D centers.
We manufacture 46 products. Our production facilities are licensed by ANMAT (Argentinean Regulatory Authority) to manufacture reagents for in vitro diagnosis and in vitro biological research. Our production facilities and processes are under compliance with Good Manufacturing Practices (GMP) standards.
We develop and manufacture products for other companies. We conduct validation studies, industrial scaling up, drafting of documents and follow-up for processes for sanitary approval, quality control, commercialization and marketing, distribution logistics.
We offer quality products, complying with the regulatory requirements and with international management standards, also offering an adequate technical support service and committing to a continuous quality improvement, maintaining the effectiveness of the Quality Management System.
We comply with the GMO standards (Good Manufacturing Practices), which guarantee the quality, safety and efficacy of the products and also comply with the ISO 13485 regulation, accredited by Det Norske Veritas (DNV).
Furthermore, most of the products we manufacture bear CE mark, in accordance with the quality standards of the European Community. Authorized representative in Europe before the Regulatory Authorities of the European Union: Medical Technology Promedt Consulting GmbH (St. Ingbert, Germany).