Life Sciences Consulting Services
Q&W provides practical, risk-based life sciences consulting services to pharmaceutical, medical device, food and cosmetics companies across Switzerland, Europe and international markets. Our multidisciplinary experts support organizations in strengthening quality systems, meeting regulatory requirements and implementing solutions that work in daily operations.
Our services cover GxP compliance, MDR/IVDR, ISO standards, pharmacovigilance, auditing, QHSE, occupational safety and business development. From initial assessment and gap analysis to implementation, training and ongoing support, we adapt each engagement to the client’s processes, risks and strategic objectives.
Our life sciences consulting services help companies improve compliance, operational readiness and sustainable performance while maintaining a clear focus on patient, product and employee safety.
Pharmaceutical Services
Q&W supports pharmaceutical companies with practical, risk-based solutions covering GxP compliance, quality management, auditing and pharmacovigilance.
- GAP analyses against applicable GxP regulations and quality requirements
- GxP audits of active pharmaceutical ingredient (API) and finished medicinal product manufacturers
- Mock inspections, self-inspections and inspection readiness support
- Quality Management Systems and documentation, including SOPs, SMF, PQR and PSMF
- External Qualified Person (QP/FvP) and QPPV services
- Pharmacovigilance and vigilance systems
- Quality risk management and risk assessments
- Quality agreements and supplier qualification
- GxP and audit training
- Product recall simulations
Contact our pharmaceutical experts: pharma@qwgroup.net
Member of
Medical Device Services
Q&W supports medical device companies in meeting regulatory, quality and safety requirements throughout the product lifecycle.
- GAP analyses against ISO 13485, EU MDR and Swiss medical device requirements
- Audits according to ISO 13485 and ISO 9001
- Quality Management System implementation and improvement
- Risk management according to ISO 14971
- Regulatory support for the EU MDR and Swiss medical device requirements
- Swiss Authorized Representative services
- Technical documentation and clinical evaluation support
- Post-market surveillance and vigilance systems
- Supplier qualification and audit support
- Regulatory, quality and risk management training
Contact our medical device experts: medical@qwgroup.net
Food Industry Services
Q&W supports food and food supplement companies in strengthening their quality and food safety systems.
- GAP analyses against ISO 22000 and applicable food safety requirements
- Audits according to ISO 22000 and ISO 9001
- Quality and food safety management system support
- Internal audits and self-inspections
- Supplier qualification and audit support
- Risk assessments and preventive programmes
- Documentation and procedure development
- Traceability and product recall simulations
- Quality and food safety training
Contact our experts: info@qwgroup.net
Cosmetics Services
Q&W supports cosmetics companies in implementing and maintaining effective quality systems and Good Manufacturing Practices.
- GAP analyses against ISO 22716 and applicable cosmetic GMP requirements
- Audits according to ISO 22716
- Good Manufacturing Practice (GMP) compliance support
- Quality Management System implementation and improvement
- Documentation and procedure development
- Supplier qualification and audit support
- Quality risk assessments
- Traceability and product recall simulations
- GMP and quality training
Contact our experts: info@qwgroup.net
Occupational Health, Safety & Environmental Services
Q&W supports companies in protecting their employees, managing operational risks and maintaining effective health, safety and environmental systems.
- GAP analyses against ISO 45001 and applicable health, safety and environmental requirements
- Audits and compliance support according to ISO 45001
- Occupational health and safety risk assessments
- Safety and health coordination
- Development of health and safety plans
- Preventive programmes and workplace safety procedures
- Environmental protection and waste management support
- Dangerous goods transport management support
- Occupational health and safety training
Contact our experts: info@qwgroup.net
Business Strategy & Development Services
Q&W supports healthcare and life sciences companies in assessing opportunities, defining growth priorities and translating strategic objectives into practical action plans.
- Strategic decision support for growth, investment and market expansion projects
- Market assessments and competitor benchmarking
- Business plan development, business model design and growth strategy development
- International market entry and expansion strategies
- Commercial due diligence and opportunity assessments
- Partner, investor and target company mapping
- Business development and prospecting support
- Strategic action plans and implementation roadmaps
- Project coordination and stakeholder alignment
Contact our Business Strategy & Development expert: contact@qwgroup.net
Let's Discuss Your Project
Need support with compliance, quality systems, regulatory requirements, audits, safety or business strategy? Our multidisciplinary experts can help you define and implement solutions adapted to your organization, risks and objectives.