Support of Post-approval Regulatory Changes

Our medical affairs professionals provide medical and scientific expertise supporting multiple areas of drug and product development, including R&D, pharmacovigilance, and regulatory processes
Our team supports post-marketing regulatory activities through:
  • Document development & creation (e.g., Core Data Sheets [CDS], Periodic Safety Update Reports [PSURs], manuscripts and abstracts, etc.)
  • Responding to inquiries from internal/external stakeholders, including R&D, regulatory, marketing, and others
  • Development of scientific strategy for product marketing, claims development, scientific publication planning, medical writing, clinical study administration, call center support; development of materials for communication with HCPs and KOL engagement
  • Development & validation of training & educational materials (e.g., slide decks, web content)

Click here to know more about our Global Regulatory Operations