Pharmacovigilance Services
The Drug Safety (Pharmacovigilance) vertical at DDReg has been involved in a wide variety of assignments which span across global markets and include USA, UK, European Union, Australia ASEAN, Maghreb countries, rest of Africa region, Saudi Arab & other GCC countries, CIS and LATAM markets. DDReg provides drugs safety services to global pharmaceutical companies, support them to manage their worldwide Safety Obligations by way of Case Management, Aggregate Reporting, Safety Compliances, Signal Detection and Risk Management.
DDReg’s comprehensive set of services across all phases of the product lifecycle are based on latest global Drug Safety/Pharmacovigilance Regulations. DDReg team is involved in drug safety services, collates, processes and compiles relevant safety information from all sources, including individual cases, published literature and clinical studies to facilitate client organizations to take decisions related to drug safety, that are logical and evidence-based.

Ensure
Comprehensive & robust safety processes

Assure
Compliance through efficient QMS & processes

Deliver
End to end solutions in a time bound manner

Manage
Safety and Risk-Benefit of drug products

Fulfill
Global Safety obligations through strong regulatory base

Case Processing
& Reporting
- Data Entry and Quality Check as per E2B/ E2B(R3) requirements.
- MedDRA Coding
- Narrative Writing
- Medical Review and Follow Ups
- Submission to Agency through Electronic Submission Gateway

Safety Writing
& Submission
-
Authoring and compilation of aggregate reports
• PADERs
• PBRERs
• PSURs
• DSURs - Annual Safety Reports – Authoring & compilation
- eSubmission of Aggregate Reports

Risk
Management
- Continuous & ongoing evaluation of Product Risks
- Compilation, Authoring and Quality check of Risk Management Plan
- Support Risk Evaluation & Mitigation Strategy
- Signal Detection, Evaluation and Reporting

Literature
& Search
- Product Literature Monitoring – MAA to Post Approval
- Medical Literature Monitoring - EMA process
- Literature monitoring for Signal Assessment

Safety Processing
Database
- E2B (R3) compliant case processing database
- Validated to comply 21 CFR part 11
- Full Gateway functionality
- Full data XML file import and export functionalities

Drug Safety
System Set Up
- Development & training of Standard Operating Procedures (SoPs) and Working Medical Literature Guidelines (WGs)
- PV QMS and PSMF Development
- QPPV/RPPV Services
- Safety Data Exchange Agreements

Products
- Product Literature Monitoring – MAA to Post Approval
- Medical Literature Monitoring - EMA process
- Literature monitoring for Signal Assessment

Markets
- USA
- EU & UK
- Saudi Arabia
- ASEAN
- Turkey
- CIS

Database Handled
- ARGUS Safety
- PcV manager
- MedDRA
- EV/FAERS
- ARIS Global
- WHO DD
- PVEdge

Agencies Handled
- EMA
- US FDA
- UK MHRA
- Saudi FDA

Functional
Expertise
- Standard Operating Procedures & Working Guidelines that define global PV standards
- Consistent & Regular monitoring & tracking of global PV Regulations/Guidelines

Operational
& Excellence
- Strong Quality Management System
- Process Consistency, Robust Templates, Proven Project Management

Robust & Secure
IS System
- Complete Data Security on Remote & in-office working
- Disaster Management
- Use of Well-established IT processes & Tools
- Skilled & Trained IT Resources

Quality
- "Our aim is to continuously meet the quality levels expected by our customers in everything we do."

Integrity
- "We display integrity at all times in the business decisions we make, the work we do and the manner in which we conduct our Business."

Excellence
- “We are passionate about people, process, product, and service excellence; For us excellence is not only a value - it is a discipline and a means for doing the business in a better manner.”

Teamwork
- “Our people strive for Excellence with sprits of teamwork.”

Commitment
- “We are committed to deliver high quality in our deliverables.”

Transparency
- “We practice openness & support that sense of doing what's right through a culture of open communications.”
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