Pharmacovigilance Services

CONSUMER HEALTH COMPLAINT MANAGEMENT, PHARMACOVIGILANCE AND POST-MARKET SURVEILLANCE SERVICES IN CANADA AND THE United States

If you are an OTC Drug, Natural Health Product, Medical Device or Cosmetic Manufacturer, Importer or Distributor seeking help with your consumer complaints, pharmacovigilance and post-market surveillance activities, contact us to see how we can help you. Focal Point Research Inc. has experienced personnel and a Medical Doctor on staff that can help relieve the stress associated with meeting the Health Canada and FDA requirements. With our expertise, we can assist with your post-market needs.

 

Focal Point Research offers the following
Pharmacovigilance Consulting Services:

COSMETICS – Cosmetovigilance
(CANADA AND USA)

  • Monitoring of all complaints pertaining to marketed products
  • Evaluation of consumer health complaints and undesirable effects
  • Reporting to Health Canada and the FDA of any serious product-related or safety-related issues

OTC DRUGS–Pharmacovigilance
(CANADA AND USA)

  • Establish and implement procedures to receive, analyze, submit and maintain Adverse Drug Reaction (ADR) records
  • ADR evaluation for seriousness and reportability
  • Facilitate filing of ADR reports to, and communication with,the Canada Vigilance Program and the FDA
  • Prepare annual summary reports and issue-related summary reports
  • Conduct literature scans, signal detection, identification of trends
  • Preparation for Health Canada Good Pharmacovigilance Practices (GVP) Inspections
  • Host or provide support for Health Canada GVP Inspections and subsequently implement corrective actions

NATURAL HEALTH PRODUCTS
(NHPs)- Post-Market
Surveillance (CANADA)

  • Establish and implement procedures to receive, analyze, submit and maintain Adverse Reaction (AR) records
  • AR evaluation for seriousness and reportability
  • Facilitate filing of AR reports to the Canada Vigilance Program
  • Prepare annual summary reports and issue-related summary reports
  • Conduct literature scans, signal detection, identification of trends

MEDICAL DEVICES – Post-Market
Surveillance (CANADA AND USA)

  • Establish and implement procedures to receive, analyze, submit and maintain Adverse Event (AE) records and/or Incident reports
  • Reporting of incidents to Health Canada and the FDA
  • Medical device market tracking, user information development and improvement post incident
  • Assisting with implementation of corrective actions following an incident occurrence

CONTACT

The Focal Point Research team of consultants is ready to help with your scientific & regulatory needs. Our friendly staff include scientists from various disciplines, regulatory and packaging experts and administrative support. We are eager to help you.

We provide our expertise to various businesses located throughout Canada and the United States, such as Toronto, Montreal, New York, Los Angeles, and many more.

GIVE US A CALL

  • 181 Lakeshore Road E. Mississauga, ON
  • mail@focalpointresearch.net
  • 1 (905) 271 2709
  • www.focalpointresearch.net

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