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Advanced MedPharma supports pharmaceutical manufacturers in achieving regulatory compliance, modernising production units and complying with international standards.
Through a combination of regulatory expertise, technical support and quality system implementation, we help to ensure operational excellence, patient safety and sustainable growth.
Understanding the Algerian regulatory framework
Algeria applies strict regulatory standards for medical devices in order to protect public health and align itself with international best practice. Any medical device intended for marketing must comply with national regulations and be assessed by the competent authority.
Our expertise enables our partners to navigate this complex process with confidence and efficiency.
Our mission
Our mission is to support local pharmaceutical manufacturers in achieving full regulatory compliance, improving operational efficiency and ensuring the highest levels of patient safety.
Accurate classification is essential, as it impacts documentation requirements, review times and approval procedures.
- Preliminary Approval Dossier
- Obtaining the preliminary approval
- Design of premises in accordance with GMP / ISO 14644
- Installation of AHU/HVAC systems according to area classification
- Layout of production areas, QC laboratory, storage areas, and airlocks (SAS)
- Installation of equipment + preparation of technical specifications
- Equipment qualification (IQ/OQ/PQ)
- Personnel training
- Opening approval dossier
- Simulation of the first MIP inspection (premises/equipment)
- Production of 3 validation batches
- Obtaining the opening approval
- Application for QC laboratory validation
- QC laboratory validation
- Product homologation / registration
- PPI for raw materials and packaging materials
- Implementation of a complete quality management system
- Scheduled internal audits
- Periodic regulatory audits / inspections
- Renewal of approvals and equipment requalification
Why choose Advanced MedPharma?
- Combining strong technical expertise with perfect command of regulations
- Focus on compliance, performance and patient safety
- Simplified registration and production modernisation processes
Become our partner
Ensure the regulatory excellence of your production units and accelerate the development of your pharmaceutical activities.
Join Advanced MedPharma as a trusted partner.
