Pharma Services
Pharma Consulting Services
Pharma Consulting Services: Toxicology, Drug Metabolism & Pharmacokinetics
Elite Consulting provides expert guidance in pharmaceutical toxicology, pharmacology, drug metabolism, and pharmacokinetics to support drug discovery and development. Our consulting services help pharmaceutical and biotech companies assess drug safety, efficacy, and absorption while ensuring regulatory compliance and optimizing candidate selection. We also help with project management.
Expertise in Toxicology, Drug Metabolism, and Pharmacokinetics
- Toxicology Services: Our team evaluates potential adverse effects of drug candidates, providing insights that help refine formulations, dosing strategies, and safety assessments.
- Drug Metabolism Consulting: We provide expert knowledge how drug candidates are processed within the body, identifying metabolites, enzymatic pathways, and possible drug-drug interactions.
- Pharmacokinetics (ADME): We offer in-depth analysis of absorption, distribution, metabolism, and excretion (ADME) profiles, assisting in designing toxicology studies for pre-clinical and clinical trials, as well as regulatory submissions.
In Vitro and In Vivo Toxicology Studies
- In Vitro Testing: Utilizing cell cultures and biochemical assays, we provide project management for cytotoxicity, metabolism, safety, and efficacy studies before advancing to live models. These studies help determine a compound’s biological activity and potential risks early in development.
- In Vivo Studies: We provide consulting on animal studies, primarily in mice and rats, to evaluate systemic toxicity, pharmacokinetics, long-term effects, and dose-response relationships. These studies are critical for predicting human responses and supporting regulatory approvals.
Bioanalytical and Clinical Trial Management Consulting
Elite Consulting also specializes in bioanalytical method development, validation, and clinical trial management consulting. Our expertise ensures precise measurement and analysis of drug candidates through advanced analytical techniques.
Area of expertise include:
- Toxicology: Comprehensive consulting for in vitro and in vivo toxicology studies.
- Drug Metabolism & Drug Discovery: Guidance on metabolic pathways, enzyme interactions, and candidate optimization.
- Pharmacology and Clinical Pharmacology: Expertise in drug action, mechanisms, and therapeutic applications.
- Pharmacokinetics – ADME: Analysis of drug absorption, distribution, metabolism, and excretion.
- Pre-Clinical and Clinical Studies: Support for study design, execution, and regulatory documentation.
- Bioanalytical Consulting: Expertise in various analytical techniques, including: (LC-MS/MS, Immunoassay, Genomics, HPLC o UV-VIS Fluorescence, Chemiluminescence)
- Method Development and Validation: Ensuring robust, reproducible, and regulatory-compliant analytical methods.
- Toxicology Mechanistic Studies: Investigating molecular and cellular mechanisms of toxicity.
- Cell Culture, Biochemical Assay, Molecular Biology, and NGS (Next-Generation Sequencing): Providing critical insights into cellular responses and genetic factors.
- Clinical Chemistry, Hematology, Toxicology, Genomics: Comprehensive consulting support in laboratory analysis for clinical and preclinical studies.
- Regulatory Compliance: Ensuring adherence to GLP (Good Laboratory Practices) and GLC (Good Laboratory Compliance) standards.
- Toxicological Evaluation: Assessing potential adverse effects and safety profiles of drug candidates.
- Preparation of FDA Regulatory Submissions: Assisting in compiling and submitting required documents for regulatory approval.
- CRO Management – Study Design, Monitoring, Compliance, and Reporting: Overseeing contract research organizations to ensure study integrity and regulatory adherence.
- Literature Reviews: Conducting comprehensive research to support drug development and regulatory decisions.
- Regulatory Strategies and Safety Toxicity Assessment: Developing strategies to ensure compliance and evaluating safety risks for regulatory approval.
Commitment to Excellence
At Elite Consulting, we are dedicated to providing high-quality, science-driven consulting services that streamline drug development processes. Our expertise ensures that pharmaceutical and biotech companies can navigate complex regulatory landscapes, optimize drug formulations, and enhance the safety and efficacy of their products.
By leveraging our specialized knowledge in toxicology, pharmacokinetics, and bioanalysis, we support the development of innovative therapies that improve patient outcomes. Whether you need assistance in study design, data interpretation, or regulatory submissions, our team is committed to delivering precise, reliable, and actionable insights.
Contact Us
Whether you’re looking for guidance on toxicology, pharmacology, drug metabolism and pharmacokinetics studies, regulatory compliance, operational efficiency, or specialized bioanalytical services, our experienced consultants offer the support you need to succeed in a competitive and regulated industry.
contact@elitelabconsulting.com
