Drug Development
our Drug Development services guide your molecule from bench to bedside, combining scientific rigor, regulatory expertise, and operational excellence to navigate the complexities of bringing new treatments to market. Partner with us to shorten timelines, mitigate risks, and unlock the full potential of your innovation.
At Horgen Med, we turn scientific discovery into life-changing therapies. As a full-service CRO, our Drug Development services guide your molecule from bench to bedside, combining scientific rigor, regulatory expertise, and operational excellence to navigate the complexities of bringing new treatments to market. Partner with us to shorten timelines, mitigate risks, and unlock the full potential of your innovation.
Why Choose Horgen Med for Drug Development?
- End-to-End Expertise: From target discovery to commercialization, we provide integrated support across all phases of drug development, ensuring seamless transitions and strategic alignment at every milestone.
- Scientific & Regulatory Mastery: Our multidisciplinary team of scientists, clinicians, and regulatory specialists delivers robust preclinical and clinical strategies that meet FDA, EMA, and global standards.
- Tailored Solutions: Whether you’re a biotech startup or an established pharma leader, we scale our services to fit your needs—accelerating early-stage research or optimizing late-phase development.
- Cutting-Edge Innovation: Leverage advanced technologies in biomarker discovery, translational research, and predictive modeling to de-risk development and enhance decision-making.
- Global Collaboration: Tap into our worldwide network of sites, labs, and regulatory partners to execute studies efficiently across diverse populations and geographies.
Our Drug Development Services Include:
- Preclinical Research: Comprehensive in vitro/in vivo studies, toxicology assessments, and PK/PD modeling to validate safety and efficacy.
- Regulatory Strategy & Submissions: Expert guidance on IND/CTA/NDA/MAA preparation, orphan drug designations, and expedited pathways (e.g., Breakthrough Therapy, Fast Track).
- Clinical Development: Design and execution of Phase I-IV trials, including adaptive trial designs, patient-centric protocols, and real-world evidence (RWE) integration.
- CMC (Chemistry, Manufacturing & Controls): Support for formulation development, analytical testing, and scalable manufacturing to ensure product quality and compliance.
- Translational Medicine: Biomarker identification, pharmacogenomics, and companion diagnostic development to personalize therapeutic approaches.
- Post-Marketing & Lifecycle Management: Phase IV studies, safety surveillance, label expansions, and lifecycle optimization to maximize product value.
- Program & Portfolio Management: Strategic oversight to align development goals with business objectives, resource allocation, and risk mitigation.
Your Vision, Our Mission
At Horgen Med, drug development is more than a process—it’s a partnership. We combine deep scientific insight with operational agility to transform your candidates into confident, market-ready therapies. Our commitment to transparency, compliance, and innovation ensures your program stays on track, on budget, and ahead of the curve.
Partner with Horgen Med to Redefine What’s Possible
Let us navigate the complexities of drug development while you focus on pioneering science. Together, we’ll accelerate breakthroughs that improve patient lives and shape the future of medicine.