CONTINUUM has the unique ability to provide integrated Regulatory and Pharmacovigilance services to our clients. This interface enables us to effectively manage our services while ensuring compliance to Pharmacovigilance regulations and executing the entire suite of Pharmacovigilance activities. Our services are designed to offer complete pharmacovigilance solutions across pre-marketing and post-marketing requirements.
Regulatory support is provided for the following Pharmacovigilance activities:
Regulatory Pharmacovigilance Services
- Quality Control of Pharmacovigilance activities
- Compliance, Audit and Validation GxP Audit Services
- QMS Remediation Services
- ICSRs and their management
- Aggregate Report Services/Periodic Safety Report Services, Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER)
- Signal Detection
- Literature Monitoring Services
Please also refer to our full range of Drug Safety services provided under the Pharmacovigilance vertical.
Dedicated Customer Teams & Agile Services
Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.