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.
Expert pharmacovigilance solutions to safeguard patients, ensure compliance, and drive innovation in drug safety. Partner with us for precision, vigilance, and regulatory excellence.
India
India - Headquarters
Pristine City Bakori Road, Wahgoli, Pune, Maharashtra - 412207
+91 90283 33221
India - Development Center
Baba Somnath Tower, Bypass Ramur Road, TP Nagar Haldwani Uttarakhand 263139
+91 90283 33221
Australia
Australia Office
ACN: 664 913 928
38 Energy Dr lyndhurst VIC 3975, Australia
38 Energy Dr lyndhurst VIC 3975, Australia
+61 4 0461 3093