, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
, HTA Coordination Group JCA Dossier guidance, and EMA's Reflection paper on patient experience data). Proficiency in R...
, HTA Coordination Group JCA Dossier guidance, and EMA's Reflection paper on patient experience data). Proficiency in R...
Compliance Ensure all CQV activities are executed in compliance with cGMP, FDA, EMA, ICH, and other applicable regulatory... of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, ICH), and industry standards. Experience...
, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies. Review and approve... resolution. Host and facilitate audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing documentation...
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...
and the security of a full support team behind you. This is a brand-new clinic equipped with EMR / EMA software, robust...
with global health authorities, including the FDA and EMA. You will be accountable for the oversight, preparation, and submission...
supervision. The practice uses EMA / EMR that supports efficient workflows and a smooth patient experience. Compensation...