Analytical Services

If your company is looking for analytical technical confidence, strategic vision, and excellence in delivery, talk to BizaLumière and discover how to accelerate your results with safety.

Analytical Documentation

• Development and review of analytical methods

• Validation and analytical transfer protocols and reports

• Forced degradation and stability studies (including photostability)

• Technical specifications for raw materials, finished products, and packaging materials

• Technical justifications for changes, deviations, or critical parameters

• Revalidation documentation and analytical batch history

• Technical data sheets, certificates, and control of reagents and analytical standards

• Version management, traceability, and document archiving

Regulatory and ANVISA

• Technical support for regulatory requirements (ANVISA and other agencies)

• Preparation of CTD-format dossiers (Modules 2 and 3)

• Technical justifications for impurities, solvents, and critical parameters

• Evaluation of DMF and CADIFA

• Review of technical documents for submission

• Stability studies and analytical batch history

• Drug–packaging compatibility assessment

• Technical support for post-approval changes (Change Control)

• Risk Assessment for Nitrosamines

• RA of Elemental Impurities (ICH Q3D)

• RA of Extractables and Leachables (packaging and contact)

• RA of Forced Degradation Products and Related Impurities

• RA of Process Impurities and Synthetic Intermediates

• RA of Contaminants in raw materials, water, and excipients

• Risk assessment in analytical processes

• RA based on FMEA, Ishikawa, and deviation history (OOS/OOT)

• RA integrated into the analytical lifecycle (ICH Q8, Q9, Q10)

Risk and Impurity Assessment

Quality

• Quality deviations and technical investigation

• CAPA preparation

• Review of SOPs and URS for equipment

• Data integrity and document management

• Laboratory safety and PPE management

• Change Control and management of technical changes

Technical training

• Good Analytical Practices (GAP)

• Technical training applied to laboratory routine

• Quality investigation tools (5W2H, Ishikawa, Pareto)

• Interpretation of OOS/OOT results

• Application of FMEA and analytical risk analysis

• Fundamentals of data integrity (ALCOA+)

Problem solving

• Operational and analytical routine failures

• Document inconsistencies and technical non-conformities

• Out-of-specification results (OOS/OOT) and low analytical robustness

• Regulatory requirements and CAPA failures

• Issues with impurities, stability, and cross-contamination

• Challenges in technical management and team training