EU Regulatory Affairs a Dossier Support, EMA, EFSA, MDR, National Authorities
Stati Uniti
Inglese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
I support businesses with structured regulatory documentation for major European pathways.
Services include:
• Strategy for EMA & national bodies (BfArM, PEI, ANSM, HPRA, FOPH, CBG-MEB)
• Clinical, technical, & EU MDR documentation support
• EFSA food, novel food, & supplement compliance packages
• eCTD module organization & gap identification
My process is highly practical. I focus on target agency requirements, compile your information into clear deliverables, and identify documentation gaps before submission.
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