Non-clinical phase is critical and sets the stage for everything that follows

IN SILICO

Performed on computer or via computer simulation’, e.g. predicting the toxicology profile of a product using its chemical structure from data-based approaches.

IN VITRO

Latin for ‘within the glass’: performing a procedure in a controlled environment outside of a living organism, e.g. use of hepatocyte (cells from the liver) cultures for metabolism studies.

IN VIVO

Latin for ’within the living’: experimentation using a whole, living organism as opposed to tissues or cells, i.e. animals, humans or plants.

Non-clinical drug development

Non-clinical Data Review and Analysis

To ensure the safety of your product our advisors will collaborate with you to establish when it may be essential to rely on other sources of openly available data.

REGULATORY SUBMISSIONS

While harmonizing the importance of the scientific discoveries with the planned indication and patient population, our team are adept at integrating available information to offer a unified solution that is suitable for the present stage of product development.

PROJECT MANAGEMENT

The development program is complex and needs solid project management and communication skills in driving multidisciplinary teams.
Our project team will understand the intended clinical plan in order to define the non-clinical plan and related activities

Regulatory Know-How > Global Reach > Strong Network

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Consumer safety and constant vigilance

NON-CLINICAL PHASE IS CRITICAL AND SETS THE STAGE FOR EVERYTHING THAT FOLLOWS.
To develop, manufacture, and commercialize a drug a company must adhere to strict regulations.

Most of the protocols will focus on safety and the added benefit to the final consumer. This is the mission of drug safety and this is the reason why this discipline plays such a pivotal role within pharmaceuticals.

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WHY WORK WITH US

RegPakBioPharma Consulting is a specialist in the entire realm of pharma.

When it comes to strategic planning for product development, it can assist with the preparation and medical writing of key proofs of satisfactory pharmacovigilance that are required for marketing authorization by the Global Regulatory Authorities.