EU & UK QPPV and/or Responsible Person (RP)

To be compliant with GVP Module-I, Sitero can offer to its customers EU & UK QPPV and RP services by duly experienced and qualified personnel with 24X7 availability to comply with EU & MHRA regulations. EU & UK QPPVs are located in EU & UK regions, respectively.

EU & UK QPPV is engaged for the following activities:

  • Oversight on client’s entire PV System for the products authorized in EU & UK regions in accordance with GVP modules
  • Maintenance and updating PSMF
  • Ensuring a full and prompt response to any request received from competent authorities
  • Complete awareness of any conditions or obligations relating to safety or safe use of the medicinal products

  • Being aware of risk minimization measures
  • Acting as single Point of Contact for competent authorities in Member States and the agency with 24X7 available and main point of contact of PV inspections

Other Drug Safety Services

Case Processing

We provide end to end (E2E) Pharmacovigilance and Clinical Safety services to Pharmaceutical, Biotechnology, and Medical Device companies.

Clinical Safety

We understand the criticality of maintaining Investigational Medicinal Product & Patient information in clinical trials.

Global Literature Search & Management

Sitero offers medical literature monitoring services by well trained and highly experienced literature experts.

Aggregate Safety Report Authoring

Sitero offers comprehensive, concise, and critical analysis of the risk-benefit balance of the medicinal products.

Safety Evaluation & Risk Management

Our medically qualified team with hands-on experience on signal management and risk minimization activities provides strategic medical support across various therapeutic areas.

Additional Services

Sitero provides wider range of other support services. We provide best-in-class one-stop solutions to our clients: regulatory intelligence, pharmacovigilance master file (PSMF) Creation & Maintenance, XEVMPD / Article 57 Database Maintenance, and PV SOPs Authoring & Maintenance Support.