Why NexusBio Partners?
Proven Experience
Our consultants' deep expertise and proven track record in working with dozens of drug and biologic products enable us to provide tailored solutions that accelerate your drug development journey. Whether you're an emerging biotech startup or an established pharmaceutical company, we partner with you to navigate complex challenges and drive your innovations forward.
We combine scientific rigor with practical industry knowledge to help you:
- Optimize development strategies
- Minimize risks
- Meet regulatory requirements
- Accelerate time to market
- Maximize resource efficiency
Partner with NexusBio Partners to transform your therapeutic vision into reality.
Small Company Focus
We at NexusBio have worked with large biotech and healthcare organizations, but our focus is on helping startup/small and medium sized companies move their drug assets from discovery to clinic using highly experienced consultants, without the organization having to commit to a full time staff member. If you are Series A or B, consider talking with us about how we can move your asset to clinic.
Small, emerging biotechs delivered over half the FDA-approved drugs, according to studies in 2022 and 2024.
Let NexusBio Partners provide you with the part time, full time, or fractional roles that you need to be successful.
Trusted Professionals with Proven Expertise
As a sponsor, you need more than guidance; you need a true partner who collaborates with you to tackle the complexities of bringing compounds from discovery to the bedside. With each of our consultants boasting over 25 years of experience, NexusBio Partners offers hands-on support to navigate the intricacies of discovery, preclinical development, operations, regulatory hurdles, and vendor management. We ensure that your programs stay on track, meet budget expectations, and comply with global standards.
Our approach goes beyond advisory—we seamlessly integrate into your operations, managing vendors, overseeing financials, and mitigating risks throughout every phase of your trial.
Flexible and Scalable Solutions
We bring a distinctive, full-spectrum solution that combines strategic insight with tactical execution. Our flexibility allows us to tailor our approach to meet the unique needs of each client, ensuring optimal outcomes.
Comprehensive Expertise Across All Phases
Our team provides tailored solutions for every stage of drug development, across a range of study phases, therapeutic areas, product types, and company profiles. Whether you’re an emerging biotech, a mid-size pharmaceutical company, or an established global player, we have the expertise to support your specific needs.
Non-clinical Preparation and Clinical Pharmacology
Our preclinical ADME/DDI and translational pharmacology experts can help move you from in vitro to in vivo, then help you navigate through IND enabling safety and toxicology studies quickly and effectively. We can help you build your preclinical strategy and develop a roadmap to a successful IND and into the clinic. From developing study designs and analyzing raw data, to developing regulatory-ready reports, we can also identify CROs and negotiate contracts on your behalf. We offer PK modeling support and will determine your first in human dosing strategy. NexusBio Partners is on your side.
CMC
NexusBio Partners has experts in manufacturing both small and large molecule drug assets, from formulation to GLP and GMP production, we can also provide QA and CMC dossier (FDA module 3) writing, review, and oversight services.
Regulatory Strategy, Intelligence, Writing, and Compliance
Navigating regulatory pathways can be daunting for biotech companies. NexusBio Partners offers strategic regulatory consulting to streamline your drug and biologic development process. Our experts understand the intricacies of regulatory requirements and will work closely with your team to develop strategies that ensure compliance and accelerate approval timelines. Let us draft your IND/CTA modules, IB, and other regulatory briefing packages. We are using highly protective and secure AI-powered platforms to accelerate regulatory filings, and at lower cost than previously available.
Clinical Trials
Designing robust clinical trials is essential for the success of any biotech product, and at NexusBio Partners we specialize in early-phase clinical trial design, providing comprehensive services to guide your biotech product from concept to regulatory approval. Our team of experts works closely with you to develop effective study protocols that meet regulatory requirements, ensuring the highest standards of efficiency and accuracy.
We offer end-to-end clinical trial solutions, including:
- Clinical Study Design: Crafting tailored protocols that optimize trial outcomes.
- RFP Development & Proposal Evaluation: Streamlining the process to identify the best partners and ensure aligned objectives.
- CRO Contracting & Management: Managing the selection and oversight of Contract Research Organizations (CROs) to ensure seamless execution.
- Clinical Program Oversight: Directly managing and monitoring the clinical trial to ensure quality, integrity, and regulatory compliance.
Our goal is to help you move your asset forward by ensuring reliable data collection, maximizing trial efficiency, and driving your product toward its next critical milestone.
There When You Need Us
At NexusBio Partners, we provide expert consulting services tailored to the unique needs of biotech companies. Our experienced team understands the complexities of drug development and is committed to delivering strategic insights that drive success.
Whether you are a startup or an established firm, we are here to guide you through every stage of your project, and we can quickly fill voids in your staffing, whether due to funding, untimely staff turnover, or part of your overall resource strategy. Then, when the time comes, we can assist with interviewing permanent staff on your behalf and ensure a smooth transition of work.