j
johncharris1

Johncharris

@johncharris1

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. Share your product type and target authority to confirm the right service.... Continua a leggere

Competenze

j
johncharris1
Johncharris
offline • 

Consulta i miei servizi

Registrazione impresa
I will consult on ema efsa bfarm pei bvl cbg meb igj foph ansm hpra registration
Documenti legali e revisione
I will write clinical dossiers for ema bfarm pei ansm foph hpra and mdr compliance