Outsourced Veterinary Pharmacovigilance (PV)

Veterinary

Pharmacovigilance

Pharmaco –

vigilance

We take one big thing off your to-do list.

Tekrolab – your full-service PV partner

We offer complete outsourcing of pharmacovigilance activities for veterinary medicinal products:

Complete pharmacovigilance services for your veterinary MPs

fully compliant with the applicable Regulations (EU) 2019/6 and (EU) 2021/1281

Adverse Event Management, Signal Detection and Risk Management

Qualified Person for Pharmacovigilance (QPPV)

Pharmacovigilance System Master File (PSMF) – preparation and maintenance

Regulatory Reporting – compliant submissions to EMA, national agencies, and global authorities

Literature Screening and Pharmacovigilance Training

24/7 Availability – ensuring round-the-clock safety monitoring and support

Global and EU Compliance – alignment with EMA, VICH, FDA, and national guidelines

Benefit–Risk Assessments – continuous evaluation and communication to regulators

Audit & Inspection Readiness – preparation, hosting, and follow-up of PV inspections

SOP Development & Maintenance – pharmacovigilance procedures fully compliant with regulations

We are here for

Human and veterinary pharmaceutical companies
Scientific and Research organizations

Universities and public institutes
Feed additive suppliers

We are here for

Human and veterinary pharmaceutical companies
Scientific and Research organizations

Universities and public institutes
Feed additive suppliers

Is it OK to outsource pharmacovigilance?

YES.

Establishment and maintenance of PV system requires experience and expertise. Outsourcing your PV duties on Tekrolab enables you to save time and resources for your core activities, ensuring full compliance with regulatory requirements.

How can Tekrolab help me with pharmacovigilance?

Tekrolab ensures EU based qualified person for pharmacovigilance (QPPV). We establish and maintain complete pharmacovigilance system and also prepare regular update of Pharmacovigilance System Master File (PSMF).

Why should I choose Tekrolab?

We do registrations in EMA databases (SPOR, IRIS, Evvet, EUDRAvigillance). We are staying up to date in this evolving regulatory environment. Expertise allows us to effectively identify, evaluate, and manage any potential adverse event or side effect related to animal medication. Well defined processes and quality control mechanisms ensure compliance with regulatory requirements.