Patient Safety Is Our Top Priority

     PATIENT & DRUG SAFETY

Development of safe drugs, biologics, vaccines and medical devices is critical to their pre- and post-approval therapeutic success. Two decades of experience working directly with the US FDA and Health Canada has enhanced our patient and drug safety expertise in the following areas:  

 

  • Clinical Trial Safety Management

  • Medical Monitoring (24/7 Physician Coverage)

  • Safety Physician Oversight

  • Case Narratives

  • Individual Case Safety Reports

  • Expedited and Periodic Reports

  • MedDRA and WHO - Drug Coding

  

  • Risk Evaluation and Mitigation Strategies (REMS) / Risk Management Plans (RMPs)

  • Clinical Safety Sections of NDAs, ANDAs, NDS and ANDS

  • Drug Prescribing Information and Product Monographs 

  • SOP Development

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