Regulatory and ANVISA: BizaLumière as a Strategic Partner in Analytical Documentation and Laboratory Quality

Pharmaceutical regulation in Brazil is one of the pillars that ensures the safety, efficacy, and quality of medicines made available to the population. ANVISA (National Health Surveillance Agency) plays a key role in this process, involving complex technical evaluations that demand precise documentation, reliable data, and robust scientific justification.

In this context, BizaLumière emerges as a strategic partner for pharmaceutical companies, offering specialized technical consulting that goes far beyond compliance: we help build solid foundations for safe regulatory decisions and consistent laboratory processes.

Regulatory Landscape and the Importance of Compliance

Regulatory compliance is not just a legal obligation — it’s a competitive advantage. Companies with structured processes can:

• Respond quickly to ANVISA’s requirements

• Reduce risks of rejection and rework

• Ensure predictability in product launches and submissions

• Reinforce their reputation for quality and reliability
  

Without proper alignment, consequences may include delays, additional costs, reformulations, and even loss of commercial opportunities and international partnerships.

Critical Points Required by ANVISA

• Consistency of analytical data

• Clarity in technical justifications

• Adequacy of supporting documents

• Traceability of all documented stages

Key ANVISA Regulations and Guidelines

ANVISA aligns with global standards, adopting the CTD (Common Technical Document) as an international reference for submissions. Key regulations include:

• RDC 200/2017 – Registration of new medicines

• RDC 73/2016 – Post-registration changes

• RDC 359/2020 – Rules for CADIFA and DMF of active pharmaceutical ingredients

These regulations define clear criteria for dossier presentation, stability requirements, impurity control, and packaging compatibility.

Technical Submissions: CTD Structure

The CTD format organizes technical and regulatory data into modules, streamlining ANVISA’s review process and aligning national practices with international standards.

• Module 2 (Technical Summaries): Summarizes quality, efficacy, and safety with clarity and objectivity

• Module 3 (Quality): Presents analytical and pharmaceutical data, including specifications, validation methods, and stability studies

A well-structured dossier ensures clarity, consistency, and regulatory alignment, reducing rework and strengthening submission credibility.

How BizaLumière Supports Your Company in Practice

BizaLumière offers specialized technical consulting in:

• Drafting and reviewing analytical documents (methods, SOPs, URS, specifications)

• Preparing CTD dossiers (Modules 2 and 3)

• Responding to ANVISA’s technical requirements with clarity and scientific grounding

• Investigating OOS/OOT, deviations, and CAPA using Ishikawa, 5W2H, and FMEA

• Evaluating impurities and residual solvents with ICH-based justifications

• Conducting stability and forced degradation studies to define shelf life

• Analyzing drug-packaging compatibility to ensure physicochemical integrity

• Critically reviewing DMF and CADIFA to ensure traceability and compliance of inputs

• Reviewing certificates and reports (CoA, GMP, technical)

• Training teams in Good Analytical Practices (GAP)

• Managing documentation and data integrity

Regulatory Responses and Post-Submission Support

After initial submission, ANVISA may request additional information. BizaLumière supports your team in crafting well-founded technical responses with:

• Logical organization and clear communication

• Consistent supporting documents (technical reports, certificates, lab results)

• Integration of analytical, pharmaceutical, and regulatory data

• Scientific justification for critical parameters such as purity, potency, and stability

This approach reduces rework risks and increases the likelihood of acceptance by the agency.

Input Management and Supporting Documentation

Regulatory compliance also depends on input quality and document traceability. We assist in:

• Critical evaluation of DMF (Drug Master File): synthesis, specifications, methods, and stability

• Technical analysis of CADIFA: verifying process consistency and pharmacopeial compliance

• Thorough review of certificates (CoA, GMP, technical reports): authenticity, validity, and regulatory adherence

Trends and Challenges in the Regulatory Landscape

Brazil’s regulatory sector follows global trends:

Trend / Market Impact

• Digitization / Faster submissions and improved traceability

• International harmonization / Facilitates partnerships and global competitiveness

• Demand for robust data / Requires greater technical investment

• Focus on inputs (CADIFA/DMF) / Ensures safety and quality throughout the supply chain
  

Stability studies, drug-packaging compatibility, and robust documentation are increasingly valued by ANVISA, requiring technical consistency and practical applicability.

BizaLumière’s Differentials

• Technical consulting, not auditing: focused on real-world applicability

• Specialized team in analytical documents that support regulatory decisions

• Clarity, consistency, and standardized scientific language

• Personalized service and post-submission follow-up

• Commitment to deadlines and the pharmaceutical industry’s routine

Conclusion: Your Technical Foundation with BizaLumière

At BizaLumière, we understand that regulatory quality is built on solid foundations of documentation, reliable data, and well-justified technical decisions.

Beyond compliance, we offer regulatory intelligence and analytical structure to turn challenges into practical solutions.

👉 Contact us to learn how we can support your team with true technical consulting.

📧 contato@bizalumiere.com.br
🌐 www.bizalumiere.com.br