Addressing the regulatory needs and supporting clinical development programs for the international Pharmaceutical Industry. Science Biotech aims to offer customized resources for the distribution of medicines and providing the best support for research and development in Brazil, resulting in new registration/licensed drugs or devices.
Selected among the 10 largest startups in the healthcare sector.
Biotech first patent sold for national pharma industry.
Partner with our clinical research sites through Science Valley.
Be our partner in development!
Extensive experience in various therapeutic areas in drug, biological and device testing, generating databases necessary for each stage of medicine.
• Identification, qualification, and selection;
• Monitoring of all documentation stages;
• Negotiation of contracts;
• Team of highly trained professionals;
• Remote and in-person monitoring;
• CTMS;
• Closing visits.
Our project management team is highly experienced in overseeing all functional areas throughout the lifecycle of a product.
• Implementation of protocols;
• Contingency and emergency plans;
• Customized strategies;
• Quick responses.
Highly qualified processes from clinical development documentation to product registrations and lifecycle management.
• Personalized regulatory strategies;
• Agency interactions;
• Regulatory and Feasibility;
• Preparation of dossiers;
• Due diligence;
• Medical devices;
• Biologicals and biosimilars (BE studies);
• License/Register;
• Food supplements.
Team of health professionals specialized in medical writing to produce scientific documents of different types related to research and for distribution in Brazil.
• Clinical study protocol;
• Informed Consent Form (ICF);
• Clinical Study Report (CSR);
• Patient questionnaire;
• Scientific publications;
• Safety, efficacy and justification reports.
The latest pillar of scientific research according to the needs of each class of medicine.
• Development of endpoint for study design;
• Sample calculations and randomization schemes;
• Statistical analysis report;
• Preparation of SAP;
• Technical Meetings.
Highly effective team to meet your needs
• Development of scientific material for presentation;
• Lifecycle management of a product;
• Medical training for internal teams and investigators;
• Monitoring activity during the clinical study;
• Participation in the Data Security Monitoring Board (DSMB);
• Commercial Launch.
Dedication to research and development of analytical methods for in vitro and in vivo quantification of drugs in different biological matrices, including human plasma, whole blood, urine and aqueous humor, through partners.
Monitoring, analysis and response to adverse events caused by the use of medications.
• Development of the Pharmacovigilance plan;
• Risk Mitigation Plan;
• Safety plan for clinical trial;
• Management of adverse events;
• Report generation.
Rua Fidêncio Ramos, 302, cj. 42
4º andar – Torre B – Vila Olímpia
04551-010 – São Paulo, SP – Brasil
0800-591-7817
contato@sciencebiotech.com.br
Article 01 Enoxaparina
Article 02 Enoxaparina
Article 03 Enoxaparina
Biotechnology has been used by the human species since ancient times. This is because, in its broadest sense, biotechnology comprises the application of microorganisms, plants and animals, to obtain processes and products of interest to society.
These molecular discoveries resulted in a technological revolution. Using recombinant DNA technology, scientists, for the first time, were able to manipulate DNA. With this technique, the isolation and manipulation of genes has become a reality. The manipulation of genes made it possible to optimize microorganisms for the production of substances in greater quantity and efficiency in the food sector. An immediately applied example was the improvement of catalase and chymosin developed by microorganisms for cheese fermentation. The same strategy used in microorganisms began to be used in the development of plants with improved characteristics. As is the case with some soybean plants that have an oil similar in composition to olive oil, that is, from this soybean we start to produce healthier oil. In fact, different sectors of society have benefited and developed viable and safe strategies for the development of Genetically Modified Organisms (GMOs) aimed at meeting consumer demands and sustainable production of food, fiber and energy.
Biotechnology will continue to provide new advances in clinical research in the coming years, leading to treatments in areas that have previously eluded us (including HIV/AIDS, cancer, asthma, Parkinson’s disease, Alzheimer’s disease), and will also continue to offer alternatives to current conventional treatments available.
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