Advancing Medical Discovery

GeneGenics provide a comprehensive range of services in nonclinical toxicology for the clinical development of biopharmaceutical, pharmaceutical drug candidates as well as medical devices. We have extensive experience with regulatory authorities which enables us to successfully address scientific and regulatory hurdles throughout the drug approval process. We specialize in the design, implementation, and management of nonclinical testing programs, from Proof of Concept, Phase I,  Phase II to full market registration support.

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ABOUT US

We are multidisciplinary scientific consulting firm that strives to develop innovative solutions. We inspire thinkers from different disciplines to combine their efforts for a common purpose. The small size of our firm enhances our flexibility, efficiency, and effectiveness, all of which translate to reduced costs and greater satisfaction for our clients.

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OUR MISSION

From, PK/PD alysis, Regulatory, to biologics and bioinformatics, and to Strategic Advice and beyond, we stimulate collaboration and help bring emerging technologies from concept to reality.

Our mission is to help your ideals, information, technology achieve regulatory milestones needed to reach commercialization.

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WHAT MAKES US SPECIAL

Out Team

We offer a comprehensive range of services to meet the changing needs of our clients

our experience

We maintain a highly trained team of multi-disciplined professionals that are ready to serve your needs

we care

Review and assessment of relevant toxicological and pharmacological data

we deliver

Our mission is to help your ideals and technology achieve regulatory milestones needed to reach commercialization.

OUR SERVICES

As a scientific pharmacological and toxicology consulting firm, we provide 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. Area of focus includes;.

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Regulatory Strategy Development
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Strategic approach
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Study Design, Monitoring and Analysis

WHY CHOOSE US

We inspire thinkers from different disciplines to combine their efforts for a common purpose. The small size of our firm enhances our flexibility, efficiency, and effectiveness, all of which translate to reduced costs and greater satisfaction for our clients.

Operational Excellence

By improving customer experience—we provide a more flexible and predictable service and lead times, while  orders at a predictable cost base

Continuous Growth

We identify improvement opportunities, focus on achieving improvements, and builds on trends that affects all our our business process.

Team of experts

 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.

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Years of experience

OTHER SERVICES

We offer full-service regulatory toxicology consulting services for drugs and biologics and medical devices. We provide support for nonclinical drug development activities including ADME,  toxicology, toxicokinetics, and safety pharmacology.

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Regulatory toxicology strategy development 

Conduct literature review and writing. Preparation of nonclinical sections of INDs and NDAs using Common Technical Document (CTD) format for regulatory filings (e.g., FDA, EMA, Health Canada). Prepare Investigator’s Brochures. Interact with regulatory agencies.

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Literature review and regulatory submission 

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Chemical Risk characterization