GloboScience
GloboScience is a strategic regulatory problem solver and product development consulting partner dedicated to creating innovative regulatory pathways to accelerate medical product approvals. With a passionate team of thought leaders, they focus on transforming discoveries into differentiated therapeutics, helping clients navigate complex regulatory environments, and delivering faster approvals and market access for life-saving products. Their expertise spans across various therapeutic areas and technologies, with a global influence and a track record of working on the fastest FDA-approved drugs.
Industries
Nr. of Employees
small (1-50)
GloboScience
Boston, Massachusetts, United States, North America
Services
Consulting engagements to design novel or accelerated regulatory pathways and end-to-end filing strategies.
Targeted interventions for programs with unfavorable health authority outcomes or failing trials to re-establish a viable path forward.
Preparation for, and support during, meetings with regulatory agencies to optimize outcomes and align on development plans.
Review and optimization of clinical study design, protocol elements, and evidence-generation strategies to strengthen regulatory submissions.
Support for label optimization, launch planning and commercialization strategies following regulatory approval.
Facilitated access to clinicians, former reviewers and regulatory executives for strategic input and program validation.
Consulting engagements to design novel or accelerated regulatory pathways and end-to-end filing strategies.
Targeted interventions for programs with unfavorable health authority outcomes or failing trials to re-establish a viable path forward.
Preparation for, and support during, meetings with regulatory agencies to optimize outcomes and align on development plans.
Review and optimization of clinical study design, protocol elements, and evidence-generation strategies to strengthen regulatory submissions.
Support for label optimization, launch planning and commercialization strategies following regulatory approval.
Facilitated access to clinicians, former reviewers and regulatory executives for strategic input and program validation.
Expertise Areas
- Regulatory strategy and submissions
- Clinical development optimization
- Cell therapy development
- Gene therapy development
Key Technologies
- Cell therapy
- Gene therapy
- Immunotherapy
- Advanced tissue products / tissue engineering
News & Updates
Get One Step Ahead Of Disease
We believe in regulatory science and medical product development as a weapon to fight disease and improve health outcomes.
2000+ Therapeutic Programs
4000+ Health Authority Meetings
100+ Countries
Get One Step Ahead Of Disease
We believe in regulatory science and medical product development as a weapon to fight disease and improve health outcomes.