Regulatory Affairs Pharmaceutical Development Project Management Quality and Audits Preclinical and Clinical Consulting/Coaching Market Access

• Expertise and hotline
• Online support: answers to your questions in real time on all topics related to pharmaceutical development and regulatory affairs
• Phoning, emails and videoconferences

• 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