We can offer the following
Quality Assurance
✓ Implementation of Quality Management
System
✓ Validation (Production Process, Cleaning,
Water Systems, etc.)
✓ Periodic Product Quality Review.
✓ Site Master File – Elaboration and Review.
✓ Preparation and DMF Review (Drug Master File).
✓ Support for assessment and GLP review – Good
Laboratory Practice
✓ Risk Management and Risk Analysis
✓ Change Control – Preparation and support for
implementation
✓ Preparation and support for Quality Policy
and Guidelines for related operations.
Manufacturing
✓ Implementation of quality management program
during the development and elaboration of
production reports (BMR), procedures, requirements,
protocols and other documentation
related.
✓ Expertise in containment measures related to
pharmaceutical products containing hazardous substances.
✓ Review of basic and conceptual Layout projects.
✓ Equipment Qualification and Process
Validation.
Audits
✓ Conduct of pre-audits for the evaluation of
compliance to ANVISA, MAP, FDA, EMA, WHO
(MOCK inspection).
✓ Support to preparation of the action plan,
and follow-up actions.
✓ International Audits – Supplier Qualification
Program (API and Finished product).
✓ Due Diligence – New Product Introdution – NPI.