Frequently Asked Questions

⁉️ What services does the consultancy offer?

We offer evaluation of analytical technical documentation (Protocols, Reports, Analytical Methods, Specifications), Stability Study reports, and technical support to respond to ANVISA regulatory requirements. Risk assessment of Nitrosamines, impurities, and E&L. Quality Management (deviations, CAPA, KPI, SOP, URS). Resolution of complex analytical problems.

⁉️ How does analytical validation work?

Analytical method validation is a fundamental process to ensure that the methods used in chemical and pharmaceutical analyses are accurate, reliable, reproducible, and suitable for their intended purpose. It is a regulatory and technical requirement that guarantees the quality of results obtained in quality control, product development, stability studies, and impurity assessment.

⁉️ What is risk assessment?

Risk assessment is a systematic process that identifies, analyzes, and evaluates potential issues that may compromise the quality, safety, efficacy, and regulatory compliance of pharmaceutical and chemical products. It is an essential part of a robust Quality Management System, applied from product development through commercialization.

⁉️Como posso entrar em contato?

You can contact us through the form on our website or by phone listed on the contact page.

⁉️ What is the importance of regulatory documentation?

Regulatory documentation is one of the pillars of the pharmaceutical industry, essential for ensuring legal compliance, product safety, traceability of technical information, and approval by national and international health authorities.

The team organizes the data in accordance with the structure required by the CTD format. It ensures that each module is built with complete and technically sound information, facilitating regulatory review.

⁉️ How does BizaLumière assist in preparing CTD-format dossiers for technical submissions?

⁉️ What are the main components of a technical summary in Module 2?

The technical summary gathers information on quality, safety, and efficacy. It presents analytical and development data in a condensed format, serving as a guide for understanding the subsequent modules.

⁉️ What type of analytical and pharmaceutical data is required for Module 3 of the regulatory documentation?

Module 3 requires detailed information on composition, specifications, analytical methods, and quality control results. It also includes stability studies and manufacturing data that demonstrate product consistency.

⁉️ How does BizaLumière provide technical support to meet ANVISA requirements after document submission?

The company prepares technical responses based on scientific and regulatory data. This support includes justifications for critical parameters, impurities, and solvents, ensuring compliance with the agency's requirements.

⁉️ What does the critical evaluation of a DMF by BizaLumière consist of?

The evaluation involves a detailed review of information about the active pharmaceutical ingredient. Aspects of quality, data consistency, and compliance with applicable regulatory requirements are analyzed.

⁉️ What are the criteria used by BizaLumière for evaluating stability and forced degradation studies?

The analysis considers the adequacy of the protocols, the statistical validity of the results, and the robustness of the methods employed. It also verifies whether the data allow conclusions about the shelf life and safety of the drug.