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Johncharris
@johncharris1
EU Regulatory Affairs a Dossier Support, EMA, EFSA, MDR, National Authorities
Vereinigte Staaten
Englisch
Über mich
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.
Share your product type and target authority to confirm the right service.
Kompetenzen
Johncharris
offline •
Meine Dienstleistungen
Gewerbeanmeldung
I will consult on ema efsa bfarm pei bvl cbg meb igj foph ansm hpra registration
Rechtsdokumente & Bewertung
I will write clinical dossiers for ema bfarm pei ansm foph hpra and mdr compliance
