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Bio-Val Consulting | Assay Development and Method Validation

Bio-Val Consulting (BVC) is a woman-owned small business (WOSB) that offers breadth of experience developing large-molecule ligand binding assays and cell based assays. With 15 years experience at the bench and performing program management with Good Laboratory Practices (GLP) compliant studies, BVC is adept at stepping through all phases of assay development and validation, including proof of concept qualification, partial or full method validation, and technology transfer. In addition, BVC offers a suite

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Bio-Val Consulting | Assay Development and Method Validation | biovalconsulting.com Reviews

<META> DESCRIPTION

Bio-Val Consulting (BVC) is a woman-owned small business (WOSB) that offers breadth of experience developing large-molecule ligand binding assays and cell based assays. With 15 years experience at the bench and performing program management with Good Laboratory Practices (GLP) compliant studies, BVC is adept at stepping through all phases of assay development and validation, including proof of concept qualification, partial or full method validation, and technology transfer. In addition, BVC offers a suite

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2 Biovalconsulting

3 Bio Val Consulting

4 woman-owned small business (WOSB)

5 large-molecule

6 ligand binding assays (LBA)

7 cell based assays

8 Good Laboratory Practices (GLP)

9 Assay Enzyme Linked Immunosorbent Assay (ELISA)

10 Electro Chemiluminescent (ECL)

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Bio-Val Consulting | Assay Development and Method Validation | biovalconsulting.com Reviews

https://biovalconsulting.com

Bio-Val Consulting (BVC) is a woman-owned small business (WOSB) that offers breadth of experience developing large-molecule ligand binding assays and cell based assays. With 15 years experience at the bench and performing program management with Good Laboratory Practices (GLP) compliant studies, BVC is adept at stepping through all phases of assay development and validation, including proof of concept qualification, partial or full method validation, and technology transfer. In addition, BVC offers a suite

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biovalconsulting.com

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Bio-Val Consulting | Assay Development and Method Validation

http://www.biovalconsulting.com/index.htm

Bio-Val Consulting (BVC) is a small business committed to helping clients meet today's demands for regulatory compliance with their bioanalytical needs. BVC's mission is to condense drug development timelines and get products to market efficiently without compromising quality or budget. BVC's clients will benefit from extensive experience gleaned from participating in over 50. Combined non-GLP and GLP compliant studies, (preclinical and clinical) phases, providing practical solutions to technological cha...

2

Bio-Val Consulting | About Us

http://www.biovalconsulting.com/about.html

Kristin H. Clement, Ph.D. Office: 704.895.8520. Mobile: 614.506.1131. Chief Executive Officer and founder of Bio-Val Consulting LLC. Has 15 years research experience developing large molecule ligand binding assays (LBAs) and cell based assays for evaluation of drug products and biomarkers. Dr. Clement was a highly successful Senior Research Scientist at a large contract research organization. Among many research endeavors, Dr. Clement specialized in testing medical countermeasures for mul...

3

Bio-Val Consulting | Services

http://www.biovalconsulting.com/services.html

Outsourcing can be a cost-effective tool for specific aspects of bioanalytical testing and technical writing. Use of a qualified consultant can streamline timelines, reduce workload burden and provide expertise not available in your laboratory at an affordable rate. BVC's services include but are not limited to the items below. Bioanalytical assays logically follow a phased approach, and Bio-Val can customize development programs that meet your exact needs. Technical Writing ranges from preparation of a ...

4

Bio-Val Consulting | Resources

http://www.biovalconsulting.com/resources.html

Provided below are useful links to sites with important information and guidelines supporting the services offered by Bio-Val Consulting. Food and Drug Administration. Center for Biologics Evaluation and Research. Guidance, Compliance and Regulatory Information. Center for Drug Evaluation and Research. Guidance for Industry: Bioanalytical Method Validation. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins. Guideline on Bioanalytical Method Validation.

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