Our Services
We Support Business Builders
Navigating the complexities of life science product development requires a strategic approach, the right tools, and extensive industry experience. At Fortino Consulting, we provide the support you need to confidently tackle each stage of your product’s journey.
Tailored Project Solutions
Every project we undertake is customized to meet the unique needs of our clients. Whether you have a straightforward query, face a specific challenge requiring a subject matter expert, or need a comprehensive solution involving a cross-disciplinary team, we deliver results that align with your goals.
Comprehensive Support
Our expertise spans various aspects of life science product development, ensuring you have the right support at every stage:
Our Support Services across the Product Pipeline
- Market Research and Intelligence
- Opportunity Analysis and Valuations
- Business Strategy
- IP Strategy
- R&D and Operational Planning
- Gap Analysis and Budgeting
- Prototyping, Costing, Supplier Sourcing
- Operational Planning (Preclinical and Early Clinical, incl. logistics and storage)
- QA/QC setup
- Product Development Processes
- Analytical Method Development
- Key Opinion Leader and Pilot Customer Recruitment
- Lead generation
- To-Market Strategy and Launch Coordination
- Quality Management Systems
- Regulatory Compliance (GMP; GLP, GCP, GDP, ISO 13485)
- Quality Assurance and Agreements
- Product Release Processes
- Auditing
- External: GMP, GCP, GDP, ISO 13485
- Supplier qualification
- Internal audits
- Gap Assessment and Risk Analyses
- Qualification and Validation
- Management Review
Training
Empowering Your Team with Essential Knowledge
Staying ahead in the life sciences industry requires continuous learning and practices for maintaining quality and to keep your team compliant and up-to-date. Fortino Consulting offers a range of training programs designed to equip your team with the skills and knowledge necessary for excellence in product development and production.
GxP Training (GLP, GMP)
- Basic and Refresher Courses: Fundamentals of Good Laboratory and Manufacturing Practices.
- Quality Assurance: Best practices for implementing and managing QA systems.
Product Development and Production
- Development Fundamentals: Key steps from concept to formulation.
- Production Processes: Scale-up, regulatory requirements, and quality control.