Quality Data...Delivered by Design™

Quality Data...Delivered by Design™



Regulatory and Pharmacovigilance Services

Our full range of regulatory services covers all stages of drug development, and encompasses manufacturing and quality, non-clinical and clinical aspects. We have experience with new and existing synthetic molecules, biologicals, as well as other novel technologies and devices. We are compliant with the requirements and guidance of the International Conference on Harmonization (ICH) and all major regional and national regulatory agencies in Europe, North America, Japan and elsewhere.

We are experienced in using the Common Technical Document (CTD) format and in adapting documentation to this format from other dossier formats.

Project size is not an issue and we are happy to take on complete programs or work on individual tasks. We are proud to offer a flexible and pragmatic approach to regulatory activities:

  • Procedural advice (European MRP, CP and DCP, Orphan Drug Designation, Borderline Substances etc.)
  • Liaison and negotiation with Competent Authorities, EMEA, MHRA etc.
  • Scientific advice, hearings, etc.
  • Liaison with Notified Bodies for Medical Devices
  • Authoring and review of IMPDs and IBs
  • Preparation and submission of CTAs and INDs
  • Application dossier preparation - MAA, NDA, NDS, etc.
  • European CE marking
  • Overall Summaries and Expert Comments

Pharmacovigilance

Verius Limited
Verius Limited

Verius Limited offers a complete range of pharmacovigilance and medical monitoring services, with a unique ability to tailor our services directly to your needs. We have global capabilities and work within all applicable regulatory and international requirements.

In today's environment there is an ever increasing focus on the safety of new products. Verius Limited can provide services ranging from a basic Pharmacovigilance service through to a sophisticated system encompassing data capture, medical review, narrative writing and electronic SUSAR reporting. Verius can offer analyses of similar events, with reports to regulatory authorities and the EMEA when necessary.

With our industry standard fully validated safety database system which is E2B and 21 CFR Part 11 compliant, we can produce ICSRs, monthly line-listings, annual safety reports and periodic safety update reports.

Starting with CRF/protocol review and investigator training through medical monitoring, safety database completion and expedited reporting to the end of study reports and case narratives, we are able to provide the pharmacovigilance expertise needed for clinical trials at every stage.

Our post-marketing services include the provision of a qualified person for Pharmacovigilance (QP PV), signal detection, literature searches, and risk management planning either on a stand alone basis or as part of the regular safety services.

With our wide experience and knowledge we offer the complete solution. We have the required skills to monitor the safety of your product from the clinical stage to marketing approval and beyond, covering clinical trials, post marketing studies, spontaneous reports and literature searches.