Tag: FDA
2 articles
Pharma Preparing for Commercialization
Managing the transition from a clinical-stage company to a commercial company is one of the most exciting and challenging times a Pharma or Biotech company has the privilege of experiencing. But it doesn't come without great planning and a little bit of luck.
pharma biotech commercialization FDA
IT and the new FDA
Historically, FDA interactions were led by Regulatory Affairs, Clinical, Quality, and the business. IT was often brought in later to implement the solution or take part in an audit.That model is quickly becoming outdated.
IT regulatory FDA IND Submission Clinical Trials Inspection Readiness