About – GeneGenics

ABOUT GENEGENICS

As a scientific consulting firm, GENEGENICS provides expert, professional services in drug regulatory strategy development. We offer a comprehensive range of services to meet the changing needs of our clients. We maintain a highly trained team of multi-disciplined professionals that are ready to serve your needs.

WHY CHOOSE US

The GENEGENICS team of scientists is committed to providing innovative solutions and exceptional support to organizations seeking to develop new drugs. We have expertise in drug development, with proven abilities in toxicology risk assessment, pk/pd modelling and simulation. We have expert capabilities in developing and executing mechanism based studies focused towards Phase 1 and Phase 2 studies, in the study design and monitoring including assay development, process improvement and technology transfer and in development of regulatory and peer-reviewed documents.

Regulatory Strategy Development

We provide consulting services on development of regulatory strategy for our clients using current regulations and/or guidance documents. We can review existing development plans (gap analysis) and provide guidance where needed. We also assist clients with regulatory agency interactions.

Efficacy, Toxicology and Toxicokinetics

We have experienced personnel and tools used to analyze toxic doses, and to determine the exposure levels at which toxic effects are observed. We provide guidance for Toxicology studies, and our scientist can provide advice whether a GLP or Non-GLP studies are appropriate

Study Design, Monitoring and Analysis

For clients in the study execution stage, we design studies, monitor at CROs and analyze data as needed. Our scope of services include efficacy and toxicology studies, while providing support for all phases of nonclinical drug development activities including toxicology, pharmacokinetics, ADME, and safety pharmacology programs.

PK/PD Analysis and Reporting

PK/PD Analysis and Reporting in Noncompartmental analyses (NCA) for GLP and Non-GLP. PK models are helpful in explaining the variability in PK data, and can identify demographic variables that might influence dosing recommendations.

Biologics

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Strategic planning

WE provide strategic planning across our client's drug development program to determine logical next steps. Whether your program is just emerging from discovery or is completing clinical studies, our consultants can help guide you in the right direction.

Projects Completed

Clients

Employess

Years of experience

WHAT PEOPLE SAY

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Abella Smith Assistant Manager

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