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!

Medical Writing

Our state of the art medical writing deliverables stand out!

Research & Development

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

Quality Assurance

Top-notch services are our goal. Quality is the essence of success.

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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

Contact Us Today!

Evaluating your Pharmacovigilance or Data Management options? Call us today to learn how MD Pharma Consulting Group can help you take the risk out of your work.