use Modernizing Medicine - EMA) Maintain adaptable and functional computer skills Respond to emergency situations based..., required SECTION 4: Knowledge, Skills and Abilities Requirements Thorough knowledge of medical terminology - required Prior EMA...
of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams...
. Ensure documents comply with company procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices...
. Ensure documents comply with Company’s procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices...
through development, database lock, and reporting/submission. Deep understanding of ICH-GCP, FDA, EMA, and other global...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
preparation of reports for sponsors. Review literature and appropriate guidances (FDA and/or EMA) in preparation for studies...
for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory... and ensuring timely resolution. Host and facilitate audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing...