VYVO BioSolutions
Consultancy focused on development and regulatory support for biological medicinal products. Offers advisory and interim services spanning product development strategy, quality systems and GMP compliance, regulatory submissions and Qualified Person services, aiming to support projects from discovery through clinical supply and market authorisation.
Industries
Nr. of Employees
small (1-50)
Products
Qualified Person Services
Contract and interim Qualified Person (QP) services for licensed and investigational medicinal products, including batch certification and importation authorization.
Product Development Consultancy
Guidance and management support throughout the medicinal product lifecycle, including strategic planning, risk management, due diligence, and technology transfer.
Quality Systems Consulting and Training
Review, design, and implementation of Quality Management Systems (QMS), GMP compliance assessments, supplier audits, and customized regulatory training.
Regulatory Affairs Support
Regulatory advice and support throughout product development, including strategy, dossier preparation, agency interaction, and regulatory gap analysis.
Qualified Person Services
Contract and interim Qualified Person (QP) services for licensed and investigational medicinal products, including batch certification and importation authorization.
Product Development Consultancy
Guidance and management support throughout the medicinal product lifecycle, including strategic planning, risk management, due diligence, and technology transfer.
Quality Systems Consulting and Training
Review, design, and implementation of Quality Management Systems (QMS), GMP compliance assessments, supplier audits, and customized regulatory training.
Regulatory Affairs Support
Regulatory advice and support throughout product development, including strategy, dossier preparation, agency interaction, and regulatory gap analysis.
Services
Interim or locum Qualified Person coverage for licensed products and investigational medicinal products, including batch certification and importation support.
Strategic planning for product development including risk management, project management and in‑licensing assessments.
Independent review and design of Quality Management Systems, GMP gap analysis and preparation for regulatory inspections.
Practical regulatory affairs advice across development stages, preparation and review of submissions, and organisation of meetings with regulatory agencies.
Tailored training courses addressing GMP, regulatory and quality system topics.
Interim or locum Qualified Person coverage for licensed products and investigational medicinal products, including batch certification and importation support.
Strategic planning for product development including risk management, project management and in‑licensing assessments.
Independent review and design of Quality Management Systems, GMP gap analysis and preparation for regulatory inspections.
Practical regulatory affairs advice across development stages, preparation and review of submissions, and organisation of meetings with regulatory agencies.
Tailored training courses addressing GMP, regulatory and quality system topics.
Expertise Areas
- Biological medicinal product development
- Regulatory compliance and submissions (EU/FDA)
- Quality management systems and GMP compliance
- Qualified Person services and clinical trial supply release
Key Technologies
- GMP manufacturing
- Analytical method validation
- Technology transfer for manufacturing and analytics
- Quality management systems (QMS)