Providing Compliant Regulatory Submissions
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Providing Compliant Regulatory Submissions
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Mickel Hedemand, Internal Advisor, Licensing Division at the Danish Medicines Agency, spoke to Andrea Charles from Pharma IQ, about the commonest reasons why companies fail first time submission and the challenges of developing globally effective submission strategies. Hedemand shares his top 3 tips for ensuring compliance with external standards and insights on what is necessary to develop a successful regulatory framework.
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Tags:
Mickel Hedemand
Danish Medicines Agency
licensing
regulatory information
pharma and biotech regulatory information
regulatory standards
submission standards
external submission standards
regulatory framework
