11 — SERVICE
CompleteRegulatoryDue Diligence.
Regulatory compliance analysis for M&A, investments and partnerships. Identification of regulatory risks and opportunities.
Method
Scope of analysis.
Complete regulatory landscape evaluation for decision making.
License Analysis
Verification of compliance for all licenses and authorizations.
- ANVISA AFE/AE
- Health licenses
- Environmental licenses
Product Portfolio
Evaluation of all products' regulatory status.
- Registration status
- ANVISA pending items
- Registration validity
Legal Compliance
Verification of compliance with current legislation.
- Regulatory compliance
- Sanitary processes
- Regulatory liabilities
Quality System
Evaluation of implemented quality management system.
- Current certifications
- Audit status
- Open CAPAs
Risk Identification
Mapping of regulatory risks and their business impact.
- Risk matrix
- Liability valuation
- Probability of occurrence
Executive Report
Complete document with findings and recommendations.
- Executive summary
- Technical details
- Action recommendations
How we work
A clear path, from diagnosis to approval.
The same method in every project: understand the product, chart the route and steer the process to a decision — with visibility at every step.
Diagnosis
Deep dive into the product, the operation and the applicable regulatory framework.
Strategy
Route definition: requirements, documentation, deadlines and owners.
Execution
Dossier preparation, filing and dialogue with the regulatory authority.
Approval and maintenance
Follow-through to the decision and post-approval management to keep everything valid.
Segments served
Evaluate before investing
Deep regulatory landscape analysis for M&A, investment and partnership decisions.