Cannabis Medicinal e BPF: Your Company is Ready for the New Regulatory Scenario?
Conformity
DRC 658 · EU-GMP
GMP Maturity
Diagnosis in 7 days
The Market Has Changed. Is Your Operation Prepared?
Increasing regulatory demands
ANVISA and international bodies continually raise the required standard.
Need for traceability
From cultivation to the final product, the entire chain needs to be auditable.
Pressure for pharmaceutical quality
The market no longer accepts operations with only agricultural standards.
Preparation for audits
National and international inspections require document readiness.
Export Requirements
Access to premium markets depends on EU-GMP and equivalences.
Regulatory risk management
Non-compliance can cost you licenses, contracts and reputation.
Those who anticipate will have a competitive advantage
Access to premium markets
Greater investor confidence
Structure ready for growth
Reduction of deviations and non-conformities
Greater operational maturity
Preparation for international expansion
How T&B Pharma Consulting Supports your Company
GMP/GMP implementation
Complete structuring according to RDC 658 and international equivalences.
Quality Management System (QMS)
Procedures, indicators and robust document governance.
Preparation for ANVISA
Readiness assessment, inspection and remediation simulation.
Gap Analysis
Prioritized mapping of non-conformities and adaptation roadmap.
Internal audits
Continuous audit program focused on sustained improvement.
Supplier Audits
Qualification and monitoring of the GxP supply chain.
CAPA
Root cause investigation, corrective actions and effectiveness.
Technical Trainings
Practical training in GMP, QMS, ICH Q9, validations and more.
Regulatory Strategy
Regulatory positioning, dossiers and interaction with ANVISA.
EU-GMP Preparation
Annex 1, Annex 7, PQR and European inspection simulation.
Why Choose T&B Pharma Consulting
Experience in regulated environments
Years of experience in pharmaceutical and biotechnology industries.
ANVISA Knowledge
In-depth knowledge of Brazilian regulations applicable to cannabis.
International GMP Expertise
EU-GMP, ICH, PIC/S and global quality references.
Multidisciplinary team
Quality, regulatory, validations, engineering and training.
Custom projects
Solutions designed for the real maturity of your operation.
Focus on results and compliance
Auditable, measurable and sustainable deliverables.
Our Working Method
- 01
Diagnosis
Immersion in the operation and understanding of the regulatory context.
- 02
Gap Assessment
Comparative analysis against GMP, EU-GMP and applicable standards.
- 03
Action Plan
Roadmap prioritized by risk, impact and deadline.
- 04
Implementation
Assisted execution with clear governance and milestones.
- 05
Training
Training teams to support the system.
- 06
Audit and Continuous Improvement
Permanent cycle of internal audit and evolution.
The Future of Medical Cannabis Will Be Led by Companies with Quality and Compliance
- Response within 1 business day
- Support from senior experts
- Guaranteed confidentiality
Urgent diagnosis
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