ONLINE SUPPORT
- Expertise and hotline (Phamaceutics, Medical Devices, MD combination products)
- Online support: answers to your questions in real time on all topics related to pharmaceutical development, regulatory affairs and medicam devices
- Phoning and emails
STRATEGIC ANALYZES
- Definition of development and registration strategies based on product specificities and regulatory requirements
- Definition of the non-clinical and clinical regulatory strategy: evaluation of the program and clinical protocols (with our partner Heathics)
- Decision support before acquiring products or records
- Audit of pharmaceutical, toxicological and clinical records
ADVICE & QUALITY ACTION PLAN
With our partner
- CGMP - FDA upgrade of production sites
- Reorganization of the Quality structure in accordance with cGMP
- ICHQ10 compliance of a Quality Management System
- Quality Risk Management (ICHQ9), deviations, CAPA
- Pre, post and inspection assistance
- State of play, Product Quality Reviews, Institution Change Requests
- Supplier's specifications
- Optimization of document systems, organization of archiving
- Writing of procedures, operating modes, quality manuals
- Design and implementation of internal trainer empowerment processes
COACHING & TRAINING
With our partner
- Coaching Personal Quality Coaching (QP, QP substitute , Operational or Functional Quality Assurance)
- Other quality personal coaching (manufacturing, packaging, control laboratory, maintenance, supply chain, ...)
- Design and animation of GMP training modules on-demand (face-to-face, webinars, e-learning, ...)
- Assessment of achievements
- Design of educational games, playful approach of GMP