MD Pharma Consulting Group

Burlington, ON · Canada

Pharmacovigilance & Drug Safetysmall

Specialization: Drug and medical device safety case processing, risk management plans

Key Differentiator

Physician-led team that handles both drug and medical device safety reporting.

Core Services

Adverse event triage and case processing; Safety database entry and reconciliation; CIOMS, MedWatch and MEDDEV reports; Risk management plans; Medical writing; Statistics and data analysis

Capabilities

Seriousness, causality and expectedness assessmentSafety and clinical database reconciliationCIOMS and MedWatch report generationMedical device vigilance (MEDDEV format)Risk management plans under GVP Module VClinical operations, monitoring and MedDRA/WHODrug coding

Market Intelligence

Office at 4145 North Service Road in Burlington, Ontario. Serves clients across Canada and the US and works to Health Canada, FDA and European NCA reporting rules.

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