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QRD Quality in Research and Development

To obtain a marketing authorization for a new medicine, it is necessary to submit to the regulatory authorities data on the efficacy and safety of the medicine and on its development process. This information must be exhaustive, complete, accurate, and traceable.

A scientist in a lab coat examines a DNA structure, analyzing its intricate details and unraveling its genetic mysteries

To help achieve this goal, we offer the following services:

Quality management for non-regulated R+D

  • Documentation & Knowledge Management
  • Data Integrity
  • Training

Good Laboratory Practices (GLP)

  • Implementation of a GLP-compliant system and preparation of standard operating procedures (SOPs)
  • Evaluation of Contract Research Organizations (CROs)
  • CRO Audits
  • External Quality Assurance Support
  • Data Integrity Support
  • Validation of computerized systems
  • GLP Training

Good Clinical Practice (GCP)

  • Implementation of a quality system in accordance with GCPs and preparation of SOPs.
  • Evaluation and review of SOPs, clinical protocols, eCRFs (electronic Clinical Records), informed consent, etc.
  • Evaluation of the submission package to EECC and CA (Ethics Committee and Competent Authority).
  • Data Integrity Support.
  • Evaluation and Audits of the Quality System:
    • CROs
    • eCRF & TMF (Trial Master File) Providers
    • Investigational Drug Manufacturers (IMPs)
    • Clinical Research Centres (hospitals, universities, laboratories, etc.)
  • Data Management and Statistical Data.
  • Validation of computerized systems (GCP and pharmacovigilance).
  • GCP Training

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