Seamless Regulatory Submission & Report Delivery
In the dynamic world of pharma, timely and compliant submissions are key. Our support services simplify the entire journey—from document preparation and formatting to validation and global electronic transmission—ensuring smooth communication with regulatory bodies worldwide.
Key Roles in Submission & Report Transmission Support
Managed services in the PV domain offer comprehensive support to pharmaceutical companies by streamlining safety operations, ensuring regulatory compliance, and leveraging technology for efficiency.
Document Management
Prepare dossiers (CTD/eCTD), manage versions, audit trails & metadata tagging.
Electronic Submissions
Use platforms like FDA ESG, EMA Gateway, Health Canada Portal; ensure regional compliance & validate XML backbone.
Compliance & Quality
Follow ICH/regional guidelines, conduct pre-submission checks, integrate safety & real-world data.
Cross-Team Collaboration
Align regulatory, clinical, safety & IT teams; communicate timelines; support accelerated pathways (e.g., Fast Track).
Post-Submission Activities
Track status, handle authority feedback, manage responses, archive records.