The NCD Company provides all services of a non-clinical development department of biotech and pharma companies with an experienced team at highest level. By outsourcing preclinical development, you will increase flexibility, save internal resources and ensure the access to a broad spectrum of knowledge and experience.
What we offer:
We save your time and internal ressources
We can complement your preclinical team or do it all for you.
We handle entire preclinical development programs or just parts of them.
We know a lot
We're experts in all aspects of preclinical drug testing for all product categories.
Our employees have worked in biotech and pharma for many years.
Every drug that makes it to market is the result of a succesful preclinical development strategy.
Knowing whether your drug has a potential benefit for patients depends on:
An ideal drug candidate has excellent chemical, physical and biological properties and a convincing efficiacy and safety profile. The aim is to ensure optimal uptake, distribution and excretion of the active substance via convenient forms of application.
Let us assist you in creating your products Target Product Profile (TPP) for development and optimization and for successful presentation to potential Investors and licences. We can help you design your Early Drug Development Plan (EDDP) for entering phase I studies. And we'll support you in deciding which studies to perform in-house and which to outsource.
Let's work together to identify the in vitro and in vivo pharmacology and ADME/DMPK studies needed for your intended indication. We ensure the best fit CRO selection for your experiments and studies. We'll develop the study plans and monitor them with the CRO, and help you Interpret, evaluate and present the results for all types of regulatory submission.
We'll support you while processing the results of early development or academic studies, and report them directly in the required format.
High legal requirements govern the scope (EMA/FDA/PDMA guidelines) and quality (GLP) for safety testing for approval to enter a drug into clinical trials.
Despite these regulations, testing strategies for individual drug groups (small molecules, biologics, vaccines, ATMPs) vary greatly, and are further influenced by company goals including indication, approval areas, milestone planning, financing and licensing models.
Together, we can develop and conduct your individual safety testing strategy. This includes identifying ideal CROs, performing CRO qualification and audit, as well as monitoring the comissioned experiments and studies in strict adherence to GLP principles. We check and interpret the data and prepare them for presentation and submission to regulatory authorities. We'll help you estimate the initial dose for first use in human clinical trials (MRSD/MABEL) and determine your products safety margins.
The criteria for summarizing, interpreting and presenting non-clinical data for clinical trial application or drug approval are stringent. We can prepare all kinds of submission documents - IND, CTA, IMPD, NDA, BDA or CAP - in CTD format, for the EMA, FDA, PMDA or other agency. And if needed for potential submission to the FDA, we'll help you create the SEND files.