Proswell experienced PV team provides a wide range of safety and pharmacovigilance services at any stage of product (drug/device) development to ensure quality and compliance.

• Safety Management Plan Development

• Risk Management Plan Development

• Literature Search & Review

• Signal Detection & Review

• Case Processing with Medical Review

• Regulatory Safety Report Development and Submissions

• Create and Maintain Study Safety Database

• Call Center

• PV Consultation

• Compliance PV System Build up/Maintenance

• PSMF Creation/Maintenance

• Clinical and Safety Databases Reconciliation