Veterinary pharmacovigilance Solutions

We Transform Your Responsibility into Our Passion

4C is equipped to support adverse events report of animal health data to the EMA and all EU Competent Authorities using the EUVeterinary guidelines as well as HL7 complaint system required by the FDA’s Center for Veterinary Medicines and as defined by the VICH. 

Veterinary pharmacovigilance is defined in Article 73 of Directive 2001/82/EC covers not only the safety aspects in animals and in humans related to veterinary medicinal products, but also other aspects of post-authorization surveillance. The system also considers any available information arising from the use of veterinary medicinal products, such as:

  • Lack of expected efficacy of veterinary medicinal products
  • Adverse reaction reports related to off-label use
  • Reported violations of approved residue limits, possibly leading to investigations of the validity of the withdrawal period
  • Potential environmental Problems

PV-Veterinary Services

  • Case Processing
  • Literature Search
  • Three Day Field Alert Reports
  • Serious Adverse Reaction Reports in Animals
  • Reports of Adverse Reactions in Humans
  •  Adverse Drug Events Reports and PSURs
  • Report Submission
  • Reporting
  • Medical Information Call Center

4C is a comprehensive healthcare solutions provider company, specializing in Pharmacovigilance, Argus Hosting, Medical Information Call Center, Regulatory Affairs, Medical Writing and Hosting Solutions

15 Corporate Place South
Suite 402
Piscataway, New Jersey 08854
USA                                  

Office: +1 (732) 529-6989
Fax: +1 (732) 529-6990          
Email:
info[at]4cpharma.com