MCR’s pharmacovigilance & drug safety support services include entire life span of the drug i.e. from its preclinical development to post-marketing surveillance. We cater to achieve and sustain utmost effective pharmacovigilance procedures, which are highly compliant with all the applicable regulatory requirements laid down by FDA, EU, PvPI.
We have expertise in:
- Set up & Maintenance of Global safety database
- Medical review of Case Report forms
- Define/CRT Documents
- Collection, Evaluation, Analysis and Reporting of Safety Information from All Sources Including Spontaneous Reports Of Adverse Events Of Marketed Drugs
- Online Coding (MeDRA, WHO DDE) Of Adverse Events
- Preparation Of safety Narratives
- Preparation of safety Narratives. Preparation and Submission of Periodic Safety Update Report (PSUR) to Regulatory Authority.
- Publishing Services Can be full Publishing or submission Ready, As Best Meets the Sponsor’s Needs
- Briefing/Meeting Packages
- Submission Ready: Fully Compliant Electronic Document Preparation ready For Sponsor to complete full Publishing For Submission to Health Authority