We Offer
Comprehensive Pharmacovigilance (PV) Solutions and Consulting Services
to global and local biopharmaceutical companies, vaccine manufacturers, medical device companies, animal health companies, contract research organizations (CROs), and academic institutes.
Delexcel is using modern safety applications leveraging technologies such as cloud and artificial intelligence (AI).
AI Intake Process
Case Management
Aggregate Reports
Partner & Agency submission
Signal & Risk Management
Content Management
Industry established processes in place.
Quality management system
Comprehensive set of SOPs in place which are regularly reviewed and updated
Document Control, Quality Control, Auditing and Continuous process improvements
Regulatory compliance
Our systems and processes are compliant with ICH E2, EMA GVP, FDA CFR Title 21, CDSCO and other regulatory regulations applicable to PV
Training
We ensure adequate training for all our staff involved in PV activities
Regular training updates and ongoing professional development
Our modern PV solutions allow us to offer:
1
Improved Compliance
2
Scalable PV Processes
3
Better Quality and Costs
Our leadership has proven track record of successful PV management in past roles.
Timely Management and Submission of ICSRs
100,000+
Aggregate Report Preparation and Submission
50+
Rescue Projects
10+
Successful Projects Transition
10+
Past project management experience for both Indian and Global biopharmaceutical companies.
