Vigilance is our key for patient safety

MD Pharma Consulting Group

Committed to patient safety, due diligence, and regulatory compliance

Pharmacovigilance

1- Drug Safety

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).

 

2- Medical Device Safety

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).

 

3- Regulatory Affairs

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 the Egyptian Ministry of Health and Population, Health Canada, FDA, and the European NCAs. 

 

4- Risk Management

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”.