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Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach

Preclinical Development

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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.

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CMC & Product Development

API Synthesis 

Safety studies 

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Drug Formulation Development

Stability studies 

Bioavailability studies 

Quality studies 

 

Analytical Development & Validation 

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Optimization 

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Quality Contol (QC)

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Quality Assurance (QA)

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Supply Chain Management 

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Technology Transfer

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Risk Management 

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CMO/CDMO Selection & Oversight

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Lifecycle Management

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Pre-Clinical Development

Toxicology 

Acute Toxicity Studies 

Subchronic & Chronic Toxicology Studies 

Genotoxicity Studies 

Reproductive & Development Toxicology Studies 

Safety Pharmacology Studies 

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Pharmacovigilance (PV)

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Drug Metabolism & Pharmacokinetics (DMPK) 

Metabolism studies 

Pharmacokinetic studies 

Absorption, distribution, metabolism, and excretion (ADME)

Drug-Drug Interaction (DDI) studies 

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First in Human 

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Early Product Development 

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CRO/CMO/CDMO Selection & Oversight

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Clinical Development 

Patient Inclusion & Exclusion Criteria 

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Patient Recruitment 

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Monitoring 

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Clinical Supply 

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CDM & Biostatistics

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San Diego, CA                                                                                                                                info@Totellinc.com

Related Topics

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Drug Discovery

Clinical Strategy &  Development

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