Regulatory Affairs
Regulations, consultations and regulatory impact.
LB InsightsRelevant information.
Relevant information.
Responsible technical analysis.
Regulatory references, quality topics and engineering issues selected for the needs of regulated organizations.
Applied intelligenceWhat has changed?
What has changed?
What needs assessment?
LB Insights distinguishes official publications from technical interpretation, with attention to source, effective date, regulatory scope and potential operational implications.
Quality
Risk management, evidence and quality systems.
Processes
Engineering, facilities, material flows and validation.
Explore topics
Areas we follow.
Explore subjects of technical interest. For current requirements, consult the original documents through the official sources provided.
Regulatory developments and their impact
Distinguishing binding regulations, consultation drafts, technical guidance and official communications.
Editorial coverage in preparation
Risk-based quality systems
Deviations, CAPA, change control, suppliers and evidence of control.
Editorial coverage in preparation
Sterile processes and contamination control
Contamination Control Strategy, aseptic operations, facilities, flows and monitoring.
Editorial coverage in preparation
Pharmaceutical engineering and infrastructure
Layouts, utilities, HVAC, cleanrooms and qualification.
Editorial coverage in preparation
Validation and qualification
Strategies, protocols, acceptance criteria and continued process monitoring.
Editorial coverage in preparation
Product and company authorizations
Licensing, registration, submissions and interaction with health authorities.
Editorial coverage in preparation
Official sourcesReliable information
Reliable information
begins at the source.
Consult official sources and original documents. Each publication should be assessed for date, version and jurisdiction.
Brazil
ANVISA
Regulations, official news, guidance, consultations and health alerts
Brazil
AnvisaLegis
Search for regulatory acts issued by the Brazilian health authority
Brazil
Diário Oficial da União
Official publication of Brazilian legal and regulatory acts
European Union
EMA
European regulatory news, publications and guidance
United States
FDA
Official information and guidance from the agency
International
PIC/S
Publications on Good Practices and inspection
International
ICH
Guidelines on quality, safety, efficacy and multidisciplinary topics
International
OMS / WHO
Technical standards and specifications for health products
Editorial standard: An enacted regulation, draft proposal, technical guidance and institutional news do not carry the same regulatory force. Any LB Quality Process interpretation will undergo review before publication, with a clear date, source and scope.