The pharmaceutical industry plays an essential role in contributing to the health of human beings by producing and validating medicines, vaccines, serums, vitamins and other inputs. It conducts clinical studies in accordance with scientific evidence standards to prove the quality, efficacy and safety of products, and maintains a pharmacovigilance system to identify problems related to the use of medications after their marketing.
Planitox is a pioneer in regulatory toxicology and has expertise in preparing technical opinions, conducting scientific work and capturing information on possible adverse events in order to ensure consumer safety and the company’s credibility. We work in pharmacovigilance from the preparation of documents to the capture of cases and their treatment.
With expertise of more than 30 years, we carry out toxicological assessment of the active pharmaceutical ingredients (APIs) produced and the calculation of the Permitted Daily Exposure (PDE), whose objective is to assess the dose at which the population can be exposed to the substance without health risks – requirements of RDC 301/2019.
What Planitox can do for your company
Whether as after hours support to the company’s own SAC, or with full-time service, our service is ideal for small and medium-sized industries whose demands are mostly related to health issues.
This means that, in addition to the traditional SAC, we extend our service to attend to toxicological emergencies and receive reports of adverse health events through a multichannel communication, with attendants trained to act with empathy, respect and agility.
Our healthcare-related service is provided by a specialized team consisting of nurses, pharmacists and doctors, who are available 24 hours a day, 7 days a week.
Our medical advice service works around the clock to guide consumers, healthcare professionals and professionals in general, in the prevention and treatment of accidents and poisoning, as well as to provide clarifications regarding the use of the product and possible damage to health.
As we understand that issues related to human health require a qualified medical staff, our team consists of nurses, pharmacists and physicians who are available to consumers and professionals 24 hours a day, 7 days a week.
Planitox operates in an integral way in the area of health surveillance, in accordance with current legislation, through specific services of pharmacovigilance, cosmetovigilance, nutrivigilance, drug surveillance and technovigilance. In order to offer greater safety to the industry and its consumers, we work in the entire process of capturing, evaluating and classifying adverse events or any problems arising from the use of a substance.
With an experienced and specialized team, with high-level academic training in the area, we also support the implementation of the surveillance system through the preparation of documents necessary to meet the demands of regulatory bodies, such as the Periodic Benefit-Risk Assessment Report (RPBR ) for the pharmaceutical industries, as well as other manuals and POPs for the other segments.
Consultancy specialized in analyzing and responding to demands from regulatory bodies — national and/or international. Acting in partnership with registered companies or consultants in the area, providing technical and scientific support for regulatory or legal action.
Calculation based on scientific methodology that analyzes the risk of a product to human health. This method is the most modern view adopted by regulatory agencies when making decisions about the release, maintenance or banning of products. Human health risk assessment is a mandatory tool for supporting toxicological dossiers on products already on the market or those whose records are being sought.
Identification of adverse effects that a substance can have on an organism. In addition to being an integral part of the product registration process, it is an essential document for the preparation of the assessment of the risk to human health arising from exposure to the analyzed substance.
Preparation of documents that attest technical information in toxicology – regardless of purpose. Whether for internal clarifications, legal demands or to support decision-making, our toxicological opinions are prepared taking into account the most current and consolidated aspects of the science of toxicology.
Consultancy specialized in providing scientific support in crisis situations related to human health. The toxicological orientation helps the company to maintain or recover its image in the face of unexpected occupational health and public health problems.
Accompaniment as a technical assistant in civil proceedings involving issues related to adverse effects, contamination, poisoning and health problems in general.
Preparation of this document required for the pharmaceutical industry in Brazil. The PDE (Permitted Daily Exposure) represents the specific amount of a substance to which the population can be exposed without any health risk. Permitted Daily Exposure Calculation is performed for hazard identification and review of relevant toxicological data.