Quality in Research & Development

To obtain a marketing authorization for a new drug, it is necessary to present to the Regulatory Authorities data on the efficacy and safety of the drug and its development process.

This information must be comprehensive, complete, accurate, precise and traceable. To help achieve that goal, Telstar offers the following services:

Quality management for non-regulated R&D

  • Documentation and knowledge management
  • Data integrity
  • Training

Good Laboratory Practices (GLP)

  • GLP System implementation and SOP preparation
  • CRO’s evaluation
  • Audit studies
  • Computerized system validation
  • Training in GLP

Clinical Research

  • GCP system implementation and SOP preparation
  • Evaluation and audits of:
  • GCP quality system of sponsors and CROs
  • Suppliers of eCRFs
  • Phase I units
  • Clinical trials/studies (TMF, sites and investigators)
  • Central and bioanalytical laboratories
  • Data management and statistics
  • Audit of IMP manufacturers (GMP for IMP)
    • Computer systems validation (GCP and pharmacovigilance)
    • Training in GCP

Telstar Value Services

We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success.

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Related Products and Services

Regulatory Affairs Compliance

Third Party Quality Audits

QA Services

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