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Regulatory, Pharmacovigilance and Medical Device Vigilance Services

 

The 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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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 aspects in compliance with national and international regulations and guidelines. Our experienced medical research support team offers a fully compliant and high-quality medical writing services support to both global and also European Union (EU) marketing authorization holders.
Our regulatory and clinical writing includes

  • Study Protocols
  • Investigator Brochures
  • Investigational Medicinal Product Dossiers (IMPD)
  • Clinical and non-clinical sections of the common Technical Document (CTD) – Chemistry including summaries and overviews for US and EU Regulatory Authorities
  • integrated Summaries of efficacy and safety
  • Manufacturing and Controls (CMC, non-clinical and clinical documents
  • Clinical Expert statements
  • Pharmacovigilance Master Files
  • Risk Management Plans (RMPs)
  • Medical Review of PSURS
  • Labeling documents- Summary of Product Characteristics (SmPC), patient information Leaflets (PIL/PL), Medication guides, US prescribing Information (USPI)
  • Clinical evaluation Reports (CER) for medical 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

Pharmacovigilance Operations -postmarketing / post Authorization

 

Our experienced pharmacovigilance global support team offers a fully compliant and high-quality pharmacovigilance services support to both global