- Need to outsource and ensure that they will get the job done right first time, knowing that do-over could terminate your program?
- Do you have a core team in place to go from bench to bedside?
- Need access to expertise that’s flexible and dependable without compromise?
- Have you done a Gap Analysis to meet regulatory expectations?
Let PharmaFacts help you navigate this process.
PharmaFacts is a global leader in the strategic planning of all facets of your late Discovery and Early Development Program. As IND-enablers… and more, we provide expert consulting on preclinical biology and analytical chemistry requirements for multiple aspects of drug development. Whether it is in the planning process, assessment of the data, or outsourcing oversight, let us help you piece together this complex process.
Need Outsourcing Help?
Our extensive knowledge of Contract Research Organizations enables us to best match the particular needs of your unique program. We can assist you with design optimization and protocols, study management, monitoring, and the appropriate report formatting. Additionally, we can help you through the next steps of the process. When safety studies identify potential adverse findings, or study related problems occur such as manufacturing, stability, formulation, absorption, analytical procedures, validation, and more – PharmaFacts can assist you in resolving these issues.
PharmaFacts can support you in navigating the regulatory processes to ensure that you meet the requirements while guiding and representing you in interactions with the agencies. In partnering with us you maximize the probability of being successful in obtaining the regulatory approval to proceed into clinical trials. Subsequently, we can assist you with required work to be performed in parallel with your clinical program. PharmaFacts helps you design investigational studies to provide mechanistic insights into issues specific to your clinical program.
Please browse the site for information on specific Services offered by PharmaFacts, use our Resources section for easy access to ICH, FDA, EPA, OECD Guidelines, and contact us if you have any questions about how PharmaFacts can better serve you or your company.