Early Stage Consultancy Services
Will your non-clinical data & development strategy be robust enough to navigate the hurdles of entering the clinical stage of development?
From discovery to post-approval, the path to market is complex—but those who tackle challenges head-on, with the right partner, gain a competitive edge.
At Simbec-Orion, we bring five decades of global drug development expertise to help you mitigate the risks, streamline processes, and accelerate innovation. Our strategic clinical development consulting solutions integrate regulatory strategy, non-clinical and IND-enabling consulting, and Phase I-IV trial design—ensuring a smarter, more efficient path to success.
Simbec-Orion has a highly experienced in-house team who can advise on your clinical development, with our external Scientific Advisory Board (SAB) available to support your more complex or specific requirements. Working with our SAB, we work efficiently and seamlessly to integrate advice and guidance into your clinical development plan.
Our services include:
- Scientific Advice meeting support, including with the FDA, EMA & MHRA
- Review of non-clinical data & design of FIH studies
- Regulatory consultancy for clinical trials, including early phase/PK studies
- Phase I protocol synopsis development
- Due diligence of non-clinical & clinical/PK data
- Standalone non-compartmental PK analysis
- Early Clinical Development Plans
- Poster / Manuscript publication
- Target Product Profile
- AI-enabled Causal Modelling
Get clinic-ready
With a consultancy program that accelerates your decision-making by providing expert guidance and synchronised early-phase services to reduce your transition timelines to first in human.
Provided via a single point of contact and a comprehensive communication plan that maximises the opportunity for success, your bespoke team of SMEs at Simbec-Orion will prepare tailored advice that:
- Unites data gap analysis, regulatory guidance, submission support, formulation development, clinic-grade manufacturing and clinical testing under one umbrella organisation.
- Reduce your time to submission by scheduling activities to move in parallel, where possible, rather than sequentially.
- Delivers an expertly designed, bespoke roadmap to FiH which not only anticipates specific program needs & mitigate risks but also reduces complexity & saves time
