PharmApprove
SSI Strategy is dedicated to building better biotechs by uniting medical innovation with robust business strategy. They offer a comprehensive range of services, including strategic medical office support, clinical development, medical affairs, regulatory affairs, and more, to help biotech companies transform innovative ideas into reality and reach milestones efficiently. Their mission is to de-risk assets, streamline processes, and accelerate drug development to ensure life-saving medicines reach patients faster. They emphasize partnership, expertise, and tailored support to overcome the unique obstacles of drug development, aiming to empower biotech leaders and drive sustainable growth.
Industries
Nr. of Employees
small (1-50)
PharmApprove
Lawrenceville, New Jersey, United States, North America
Services
Strategic alignment of medical functions to ensure scientific integrity, patient advocacy and stakeholder engagement across development programs.
Planning and execution support for translational research and clinical development from preclinical through early and late clinical phases.
Operational leadership for clinical trial execution, resource planning and investigator engagement.
Evidence generation strategies for payers and regulators including HTA positioning and value communication.
Design and operationalization of medical affairs functions, stakeholder engagement and scientific communication.
Governance design, portfolio prioritization and program oversight to align development with business inflection points.
Strategic alignment of medical functions to ensure scientific integrity, patient advocacy and stakeholder engagement across development programs.
Planning and execution support for translational research and clinical development from preclinical through early and late clinical phases.
Operational leadership for clinical trial execution, resource planning and investigator engagement.
Evidence generation strategies for payers and regulators including HTA positioning and value communication.
Design and operationalization of medical affairs functions, stakeholder engagement and scientific communication.
Governance design, portfolio prioritization and program oversight to align development with business inflection points.
Expertise Areas
- Clinical trial management
- Translational and early clinical development
- Chemistry, Manufacturing and Controls (CMC) for small molecules and biologics
- Advanced Therapy Medicinal Products (ATMP) development
Key Technologies
- Clinical trial design and endpoint modelling
- CMC development and stability planning
- ATMP product development methodologies
- Regulatory submission frameworks (IND/MAA) and briefing materials
News & Updates
Join our experts on Thursday, 5th June at 14:00 BST for the webinar on the European Health Technology Assessment (HTA) regulation.
Join our experts on Thursday, 23rd January at 14:00 UK for the third installment of our webinar series on the European HTA regulation.
Join our webinar series on the upcoming European HTA regulation on Thursday, 10th October.
Join our webinar on Thursday, June 27th, 2024, to understand the new EU HTA regulation and its implications.
Join our experts on Thursday, 5th June at 14:00 BST for the webinar on the European Health Technology Assessment (HTA) regulation.
Join our experts on Thursday, 23rd January at 14:00 UK for the third installment of our webinar series on the European HTA regulation.
Join our webinar series on the upcoming European HTA regulation on Thursday, 10th October.
Join our webinar on Thursday, June 27th, 2024, to understand the new EU HTA regulation and its implications.