Zodiac Pharma is a Global Leader in Regulatory Consulting and Dossier (CTD, ACTD & ROW Dosssier) Solution
Format : EU / CIS Guideline
Periodic Safety Update Report includes:
- Worldwide marketing authorization status
- Overview of exposure and safety data
- Actions taken in the reporting interval for safety reasons
- Changes to reference safety information
- Estimated exposure and use patterns
- Summaries of significant findings from clinical trials in the reporting interval
- Findings from non-interventional studies
- Information from other clinical trials and sources
- Non-clinical data
- Literature
- Discussion and conclusions on PSUR data
Send Product name for which you need PSUR by email:- info@zodiacpharma.com
Our Team will review your PSUR requirement and Revert ASAP.
Our team will send quotation (price, delivery time and PSUR index for your approval)
- Complete Support on PSUR (handling all MoH queries if its raised during registration)
- PSUR expertise -Dedicated PSUR professionals (Knowledgeable & Experienced)
- High quality Database (Reference EU submitted PSUR)
- Since 2008, Over 11 years of experience in global regulatory environments
- Highest quality @ reasonable price
- Confidentiality and On-time delivery
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