MEDICAL AFFAIRS AND VIGILANCE

MEDICAL AFFAIRS AND VIGILANCE

Analyzing Scans

Your vigilance partner on the ground

Product Types

Finding the correct approach to product registration.

Vicore specialises in medical affairs services and vigilance requirements of the following product types across a range of therapeutic areas:
-    Pharmaceutical Medicines
-    Complementary Medicines
-    Medical Devices and IVDs
-    Cosmetics

-    Borderline Products

Services

PV Oversight for MAH

  • Oversight of Adverse Drug Reaction, Product Quality Complaints and Medical information for pharmaceuticals and medical devices

  • QPPV contracts and notifications to Regulatory bodies

  • Periodic reconciliation of PV information 

  • Database and access logs

PV Management

  • PV report center

  • Audit preparation and auditing

  • Consultancy and guidance for the development of SOPs and PV practices 

PV Intelligence

  • Surveillance of regulatory changes, communication and escalation as required

Medical Information

  • Resource provision and customer centric query resolution

Literature Screening

  • Review of medical literature and escalation of adverse events

Medical and Commercial Excellence

  • Product and therapy area training