How can MINOMA help you?
WHAT CAN WE DO FOR YOU?
MINOMA can help you with your legal roles, auditing, interim management, project management, training, coaching, and so much more. Below you can find an overview of different areas in which we can help and support you.
Contact us to learn more
Quality and GXP/ISO 13485 compliance
- Set-up or improvement of quality management system (GMP, GDP, ISO 13485)
- GMP/GDP/ISO 13485 inspection preparation and remediation
- Data integrity
- Sterility assurance management
- Qualification & validation
- Quality risk management
- FMD – serialization
- Preparation and submission for diverse licenses in BENELUX
LEGAL ROLES
- Qualified Person - medicinal products
- Responsible Person GDP
- Person responsible for regulatory compliance - medical devices
- Authorised representative within EU – medical devices
AUDITING
- Contract Manufacturing Organisation
- Material suppliers (API, excipients, packaging materials)
- Sterilisation services
- Storage and transportation
PROJECT MANAGEMENT
- Facility design and manufacturing start-up activities
- New product introduction
- Product transfer
- Improvement projects (quality, manufacturing, organizational)
INTERIM MANAGEMENT
Interim management for manufacturing operations from API to packaging
Interim management for quality assurance for medicinal products and medical devices (sterile/non-sterile)
COACHING
Coaching of junior QP
Coaching of junior RP GDP
Coaching of QA personnel
Coaching of production personnel
TRAINING
- Basic and advanced courses on quality systems (GMP, GDP, ISO 13485)
- Courses on European – Belgian – Dutch legislation on medical products and medical devices
- European and Belgian requirements for medical samples
- General courses on regulatory affairs
- Sterilization and aseptic techniques
- Quality risk assessment
Neerstraat 83
3150 Wespelaar
Belgium