

Pharmacovigilance
Vigilance is our key for patient safety. Patient safety is our primary and main objective!

Statistics & Data Analysis
We choose the right statistical tool and computational model to analyse your data.

Clinical Operations
We streamline clinical operations to provide efficacious solutions for complex projects.

Medical Consulting
Exceptional medical consultations to pharmaceutical and medical device companies!


Research & Development
We support drug development pipelines from benchside to "market"side.



Pharmacovigilance
Vigilance is our key for patient safety. Patient safety is our primary and main objective!
Pharmacovigilance
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).
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).
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 Health Canada, FDA, and the European NCAs.
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”.
Clinical Services
Professional Training
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