

Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach
Preclinical Development
This vital phase in the R&D continuum ensures that your drug candidates are safe, effective, and producible before testing in humans. Our professionals excel in providing comprehensive preclinical support, including designing, opmizing, overseeing, and evaluating toxicology studies and PK/PD studies. Additionally, they are highly experienced in heading pharmacovigilance (PV), formulation development, and manufacturing process development efforts.
Our experienced consultants work closely with your team to design robust preclinical programs, optimize experimental protocols, and navigate regulatory requirements. This will allow you to advance your pipeline confidently to the clinical stage while minimizing risks, expediting the path to successful clinical trials, and conserving resources.
CMC & Product Development
API Synthesis
Safety studies
Drug Formulation Development
Stability studies
Bioavailability studies
Quality studies
Analytical Development & Validation
Optimization
Quality Contol (QC)
Quality Assurance (QA)
Supply Chain Management
Technology Transfer
Risk Management
CMO/CDMO Selection & Oversight
Lifecycle Management
Pre-Clinical Development
Toxicology
Acute Toxicity Studies
Subchronic & Chronic Toxicology Studies
Genotoxicity Studies
Reproductive & Development Toxicology Studies
Safety Pharmacology Studies
Pharmacovigilance (PV)
Drug Metabolism & Pharmacokinetics (DMPK)
Metabolism studies
Pharmacokinetic studies
Absorption, distribution, metabolism, and excretion (ADME)
Drug-Drug Interaction (DDI) studies
First in Human
Early Product Development
CRO/CMO/CDMO Selection & Oversight
Clinical Development
Patient Inclusion & Exclusion Criteria
Patient Recruitment
Monitoring
Clinical Supply
CDM & Biostatistics
San Diego, CA info@Totellinc.com
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