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Regulatory, Pharmacovigilance and Medical Device Vigilance Services

 

Research & analytics service also include product development, process modeling development, ontology services, healthcare market research and data science, including algorithm development for building ML modeling.

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Pharmacovigilance Operations -postmarketing / post Authorization

 

Our experienced pharmacovigilance global support team offers a fully compliant and high-quality pharmacovigilance services support to both global and also European Union (EU) marketing authorization holders. We offer up-to-date pharmacovigilance services for drugs and vaccines that hold a marketing authorization.

    Our post marketing pharmacovigilance services includes:

  • Case processing (ICSRs)
  • Expedited reports
  • Preparation and Submission of the Periodic Benefit Risk Evaluation Report PBRER, or Period Safety Update Report (PSUR)
  • Global Literature Search and Screening
  • Local Literature Review
  • Safety Signals
  • Reviewing and update of study documentation, including investigator brochure and protocol

Our medical device vigilance services compliant to the new EU MDR and MEDDEV 2.7/1 Rev 4 guidelines or CFDA or TGA requirements and our specific services include:

  • Clinical Investigation Plans
  • Feasibility studies / pilot studies
  • Device Vigilance Report Preparation
  • Medical Assessment
  • PMS Plans / PMCF plans
  • Post marketing / Observational studies
  • PASS (Post authorization Safety Studies)
  • ADE and MDI Reconciliation
  • Clinical Development for Pivotal Studies
  • Post Marketing Clinical Follow Up studies
  • Literature Search /reviews
  • Publications
  • Biometrics Services
  • Across all therapeutic areas of all classes of devices

Regulatory, Pharmacovigilance and Medical Device Vigilance Services

We have helped our clients succeed in hundreds of product development projects.

Regulatory Submission Review

 

Our experienced pharmacovigilance team help to assure the quality and integrity of data submitted to the FDA

Regulatory and Clinical Writing

 

Medical Writing is an integral part of clinical research and Guires has extensive experience and expertise in the non-clinical and clinical and regulatory