Pharmacovigilance
MD Pharma Consulting Group provides pre-market and post-authorization pharmacovigilance services for drugs that include:
- Triage of the received Adverse Events.
- Assessment of seriousness, causality, and expectedness.
- Data entry into the safety database.
- Reconciliation between safety and clinical databases.
- Safety report generation (CIOMS / MedWatch).
MD Pharma Consulting Group provides pre-market and post-authorization pharmacovigilance services for medical devices that include:
- Triage of the received Adverse Events.
- Assessment of seriousness, causality, and expectedness.
- Data entry into the safety database.
- Reconciliation between safety and clinical databases.
- Safety report generation (MEDDEV).
As soon as MD Pharma Consulting Group receives a notification of a serious adverse event, the regulatory reporting time clock starts. MD Pharma Consulting Group shows extreme diligence in observing the regulatory submission guidelines enabling prompt regulatory compliance with Health Canada, FDA, and the European NCAs.
MD Pharma Consulting Group prepares the Risk Management Plan and supports the submission process to the regulatory agencies in accordance with “Module V of the Guideline on Good Pharmacovigilance Practices”.