Our services
What we offer
Gap analysis
For companies working toward critical steps like preparing a development plan, reaching to investors, readiness for Scientific Advice or CTA/IND submissions, Biotherapy Partners identifies potential gaps between the existing data package and the requirements of the final dossier. Biotherapy Partners experts will identify potential R&D or regulatory challenges, will assess if non-clinical findings are in line with planned clinical programs, will help creating a development program supporting the anticipated regulatory strategy, will consider technologies that may increase the benefit/risk ratio.
Key questions will be asked & answered:
- Are the data collected sufficient to support the development plan?
- Are we leveraging the most relevant non-clinical models and technologies?
- Is the data set available sufficient to support the desired regulatory strategy and the goals of the target product profile?
Strategic and Operational Support
Biotherapy Partners assists project holders to design, implement and execute drug development strategies. Our seasoned consultants define with clients the work plan to reach specific goals within timelines (Due diligence & Gap analysis), then helps internal resources to organize your drug development program (program management), define & interpret experimental studies during the operational phase of the project.
We support the development of new products from discovery stage to clinical-stage and up to commercial products, including proof of principle, CMC development, non-clinical development, regulatory advice & consultations to achieve significant milestones in your drug development program.
Coaching / Training
Biotherapy Partners provides various trainings for our clients, like online courses on cell and gene therapies, drug development in industry, considerations for manufacturing, key elements for regulatory strategies or tailored / in-house coaching programs throughout the biologics development lifecycle management.
Due diligence
Biotherapy Partners performs due diligences for biotech or pharmaceutical companies and for investors to evaluate the available data package and development plan of pharmaceutical drugs, new technologies or services to assess robustness and expectations, in line with industry standards, company product portfolios, target indication ecosystem and more.
