Totell.bio
CMC & Product Development
Our consultants provide expert guidance in both upstream and downstream services, ensuring your products' quality, safety, and efficacy. From early development through commercialization, we optimize your manufacturing processes and regulatory submissions, paving the way for successful product approvals.
Our product development team partners with you to transform innovative ideas into market-ready therapies. We offer comprehensive support through all phases of development, from preclinical research to clinical trials, ensuring your product reaches the patient population that needs it.
CMC
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 (to manufacturing sites and CMOs)
Risk Management
CDMO Selection & Oversight
Lifecycle Management
Pre-Clinical
Toxicology
Acute toxicity studies
Subchronic & Chronic toxicology studies
Genotoxicity studies
Reproductive & Development tox 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 Selection & Oversight
Clinical
Patient Inclusion & Exclusion Criteria
Patient Recruitment
Monitoring
Clinical Supply
CDM & Biostatistics
San Diego, CA info@Totellinc.com
