Services

Consulting Services

Lab Consulting Services
Medical Laboratory
At Elite Lab Consulting, we strive to create unique solutions that produce results based on 25 years of laboratory experience and knowledge. Our goal is to ensure our customers can achieve their goals for regulatory and technical compliance, lab management, and financial success. Our work is centered around creating strategies, workflows, and tests to help achieve your desired outcome.
We Provide:
Area of expertise include Clinical Tests, Toxicology, Clinical Chemistry, Pain Management, Hematology, Molecular, Genetics, Pathology, Infectious Disease, Wound Testing, Covid, Allergy Testing, Diagnostic Immunology, Waived Testing, Moderate Complexity, LDT- Laboratory Developed Tests, and Direct to Consumer.
TESTIMONIALS
Our Happy Clients
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Contact Us
Whether you’re looking for guidance on regulatory compliance, operational efficiency, specialized testing services, or starting a laboratory, our experienced consultants offer the support you need to succeed in a competitive and regulated industry.
contact@elitelabconsulting.com
Pharma Consulting Services
Pharma Consulting Services: Toxicology, Drug Metabolism & Pharmacokinetics
Elite Consulting specializes in pharma toxicology, drug metabolism, and pharmacokinetics, providing expert guidance to pharmaceutical companies in drug discovery and development. We help to assess drug safety, efficacy, and absorption, ensuring regulatory compliance and optimizing candidate selection.
With expertise in toxicology, Elite Consulting evaluates potential adverse effects, helping to refine formulations and dosing strategies. Our work in drug metabolism focuses on understanding how drug candidates are processed in the body, identifying metabolites, and predicting interactions. In pharmacokinetics, we provide insights on drug absorption, distribution, metabolism, and excretion (ADME) profiles, providing assistance in designing toxicology studies for pre-clinical and clinical trials and data review for regulatory submissions.
A key part of our toxicology services includes consulting services for in vitro and in vivo testing. In vitro studies use cell cultures and biochemical assays to assess cytotoxicity, metabolism, safety and efficacy before advancing to live models. In vivo studies involve animal testing, primarily in mice and rats, to evaluate systemic toxicity, pharmacokinetics, and long-term effects. These studies help predict human responses, identify potential risks, and support regulatory submissions.

We also provide bioanalytical and clinical trial management consulting services.
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.
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