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S10 Photosafety Evaluation of Pharmaceuticals



Last Updated (Saturday, 14 February 2015 15:44)


Pharmaceutical Consulting & Outsourcing Management

  • Do you have your core team structure in place for taking your Discovery program into Development?
  • Do you now need access to a pool of talent that you can flexibly, but dependably use without having to compromise?
  • Do you need to outsource but need to ensure that they will get the job done right, first time, knowing that do-over could kill your program?
  • Not quite sure where to find those people or those vendors?  Or you're looking but don't know whether they are a good fit?
  • Do you have a rough plan but know that there are gaps or you're not quite sure whether this would pass the regulatory expectations, and then how do you go about asking anyway?

Then you have come to the right place - we can help.

Strategic Planning

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 confidently and competently provide expert consulting on pre-clinical biology requirements as well as chemistry requirements for multiple aspects of drug development, whether it is in the planning process, assessment of the data or outsourcing oversight, helping you to piece together this complex process.

Need Outsourcing Help?

Our extensive knowledge of Contract Research Organizations enables us to point you to multiple options in your choice of vendor and service to best match the particular needs of your unique program.  We then can assist you with design optimization and protocols, study management and monitoring and the appropriate presentation of the findings and what to do next when safety studies result in positive findings or there is a problem with manufacture, stability, formulation, absorption, analytical procedures and validation, just to mention a few of the challenges that can arise along the way.

Regulatory Needs?

PharmaFacts also supports you in stepping through the halls of the regulators making sure that you meet the requirements, guiding and representing you in interactions with the agencies. In partnering with us you maximize the probability of being successful in obtaining the go ahead to proceed into the clinic.  Once there we can then assist you with the additional work that must run in parallel with your clinical program and the planning and execution of all the studies that you must undertake to continue to meet preclinical safety requirements.  Not only that, PharmaFacts also helps you design investigational studies to provide mechanistic insights into issues specific to your clinical program.

The Details...

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.

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