- Regulatory Affairs
- Clinical Operations
- Data Management
- Medical Services
- Quality Assurance
- Biotech Consultancy
- PRO Services
- Oncology Trials
- Internal Medicine Trials
- Observational Studies
- Medical Monitoring
Our focused biotech unit will chart the right path for each of our biotechnological client’s product.
In a marketplace where more than ever biotechnology companies are playing a crucial role within the clinical development arena, Pivotal has built a focused unit to address their needs. We understand the pressures to prove the potential of a compound or device with limited in-house resources, regulatory requirements and challenging funding access. Therefore, at Pivotal we offer our biotechnological clients ongoing strategic advice and process-driven platforms to achieve their critical and important key milestones quickly and efficiently.
Our consultants bring deep regulatory and therapeutic expertise to asses, develop and implement an effective plan to ensure the success of a product’s development at every stage. The unit is lead by Dr. Pablo Ortiz who brings to the company over 30 years of broad-based clinical research and senior management experience in both large pharmaceutical and biotechnological companies. Previously to joining Pivotal, and during 8 years, he was the founder and CEO at Digna Biotech (2004), a Spanish based biotech company created as a spin-off of Navarra University. He lead the company’s strategic planning, completed a €60mm fund raising and advanced four IMPs to clinical stage (one small peptide, two proteins and one viral vector).
Services we provide:
- Regulatory advice and planning (IMPD, Orphan status, Competent Authorities/EMA interaction)
- Clinical Development Plans (design and execution)
- Provide support to apply to access public funding (EU programmes)
A well designed development programme can make the difference between failure and success, we will only focus on those essential activities to achieving the specific requirements, minimise risks and control costs throughout the development process.