What we do
We provide cross-disciplinary support across critical development areas:
- Preclinical Development
- Lead optimization
- In vitro and in vivo studies
- Candidate selection
- Chemistry, Manufacturing & Controls (CMC)
- Process development
- Scale-up strategies
- Quality control systems
- Translational Pharmacology
- PK/PD modeling
- Biomarker development
- Mechanism of action studies
- Toxicology & Pathology
- Tox study design
- Tox study management
- Safety assessment
- Risk evaluation
- Pathology interpretation
- Clinical Development
- Regulatory
- Strategic planning
- Regulatory intelligence
- Documentation preparation
- Agency submissions
- Agency interactions
- Regulatory compliance
- Clinical Trial Management
- Protocol development
- Clinical Trial Leadership and Operations
- CRO Selection and Qualification
- KOL Development and Management
- Scientific Advisory Board Development
- Quality Management
- GCP auditing
- Inspection readiness
- SOP development
- Regulatory
- Business Operations
- Accounting/finance
- RFP development
- Vendor proposal evaluation
- Contract negotiation
Our team consists of experienced scientists and regulatory, manufacturing, program management, report writing, toxicology, pathology, accounting/finance, and vendor management experts who are passionate about biotechnology and dedicated to achieving your mission.
What's more, our team is highly effective while working remotely and can provide your organization with the skills you need, as you need them, without a long term commitment required of a full time staff member.
Let NexusBio Partners be your partner in your drug development journey!