DH, have not worked in BioTechs field. Worked in pharmaceutical industry 20 years ago now (Biotechnology was in it's infancy then) - was Regulatory Affairs Manager for an Australian Company but now retired. Had dealings (relating to product registration and compliance issues) with the FDA and visits to Rockville for formal meetings. The majority of the time we worked in conjunction with consultants and regulatory staff of US partner companies.
General principles that apply to conventional pharmaceuticals with respect to saftey and efficancy and manufacturing still apply to BioTechs though with a few more complex idiosynchracies particularly with respect to manufacture and quality assurance of the active component.
VLA Price at posting:
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