Clinical Development & Scientific Advice
Clinical Development & Scientific Advice
Strategic Pathways for Science, Regulators, and Investors
Drug development is a journey — complex, capital-intensive, and shaped by regulatory expectations. To succeed, sponsors need more than operational support. They need a strategic partner who understands science, regulators, and investors alike.
At Astrum, we help innovators design development pathways that are credible to regulators and compelling to investors. From preclinical planning through Phase IV, we align study design, regulatory milestones, and budgets to ensure every step advances both your science and your business.
Integrated, End-to-End Expertise
Our cross-functional team provides guidance that connects strategy with execution:
Program & Regulatory Strategy
integrated preclinical, clinical, and regulatory planning for drugs, devices, and advanced therapies.
Regulatory Interactions
preparation and support for EMA, FDA, and EU authority advice meetings, ensuring alignment from the outset.
Submission Excellence
regulator-ready documentation including IBs,
IMPDs, and CTAs.
Study Design with Impact
trials tailored to meet scientific rigor, patient safety, regulatory compliance, and investor milestones.
Whether you need full-spectrum guidance or targeted functional support, Astrum ensures your
development pathway is both regulator-approved and investor-backed.
Why Astrum
Investor-Aligned
Strategy
Milestone-driven pathways designed to unlock capital and partnerships.
Global European
Reach
seamless integration with Astrum’s Phase I Porto unit and European clinical network.
Trusted
Credibility
EMA, FDA, and ANVISA audited operations with proven inspection success.
Agility for
Biotechs
practical, efficient solutions tailored to smaller companies moving at speed.
Ready To Move Forward?
Discuss your development pathway with our experts
Ready to design your next trial? Let’s build your plan together
From early development to Phase IV
Let’s Move Your Science Forward.
Discover how Astrum supports biotech and pharma with end-to-end
clinical trials designed for success.