S10 Photosafety Evaluation of Pharmaceuticals
Last Updated (Saturday, 14 February 2015 15:44)
Pharmaceutical Consulting & Outsourcing Management
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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.
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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.
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.
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