Blood, blood products, tissues for transplantation and Stem Cells
Not too long ago, talk of such medical miracles occurred only in science fiction. Today, most people fear that ideas such as these are advancing faster than the ability to regulate them. Uncertainty especially as "state of the art" is routinely exceeded fuels the general public's call for caution and you to have to contend with an ever-increasing regulatory burden.
We can help demystify the complex regulatory maze and help you become accredited quickly and efficiently.
Using the power of our experience, our laboratory and biotechnology experts bring clarity to such complex issues as:
- . AABB, FACT accreditation
- . USFDA cGMP, cGLP, cGTP or cGTP compliance
- . Health Canada and European compliance
- . ISO Quality Management System implementation/registration
- . Product safety testing, verification and validation
- . Collection, processing and manufacturing
- . Internal audit with an emphasis on continuous improvement
- . Scaling up from research to worldwide distribution
- . IDEs, INDs or Biological Licenses - it means market access and
- revenue generation.