Patient Well-Being Is Our Core Value

   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 safety expertise in the following areas:  

• Clinical Trial Safety Management

• Medical Monitoring (24/7 Coverage)

• Safety Physician Oversight

• Case Narratives

• Individual Case Safety Reports

• Expedited and Periodic Reports

• MedDRA and WHO - Drug Coding

• SOP Development

• 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 

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