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Johncharris
@johncharris1
EU Regulatory Affairs a Dossier Support, EMA, EFSA, MDR, National Authorities
États-Unis
Anglais
À propos de moi
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.
Compétences
Johncharris
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Voir mes services
Immatriculation d'entreprise
I will consult on ema efsa bfarm pei bvl cbg meb igj foph ansm hpra registration
Documents juridiques & Révision
I will write clinical dossiers for ema bfarm pei ansm foph hpra and mdr compliance
