Verified recordBiotechnology Research

Eva Marcon

Senior Manager Drug Device Combination at Amolyt Pharma

Based in Paris, France

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Seniority

Manager

Department

Research & Development

Location

Paris

Industry

Biotechnology Research

Company size

21

Contact information

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Email

1 credit

e•••••••@amolytpharma.com

Phone

5 credits

+33 ••• •••• ••••

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Background

About Eva Marcon

Quality and Regulatory expertise in development of innovative medical device and/or combination product (drug delivery system), Design Control SOP Implementation in pharmaceutical Quality System Management, with current Good Manufacturing Practice, Risks Management, CAPA Management, Change Control management, compliant to Quality by design, 21 CFR part 4 and 820, ISO 13485 and EU regulation 2017/745 (MDR), for BLA submission, CRL remediation (US market) and MAA submission (EU market).

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