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Regulatory Services, Medical Writing, Compliance, Auditing, Safety, PV

  • Writer: Freyr Global Regulatory Solutions
    Freyr Global Regulatory Solutions
  • Jan 8, 2018
  • 1 min read

Freyr’s Scientific and Medical writing team has proven expertise in delivering world-class Regulatory and Medical Writing services for its growing clientele of (global large) Pharma, leading CROs and other Biotech companies adhering to stringent timelines and high-quality parameters. Freyr is a preferred global Medical Writing services provider for both writing and document level publishing requirements.

Our compliance experts work closely together on local and international Regulatory and compliance challenges and offer specialized GxP audit, QMS Remediation, Process and Product Validation and GxP Solution consulting services to assist Life Sciences organizations comply with Health Authority requirements.

Regulatory Medical Writing Expertise

  • Clinical Services

  • Regulatory Writing Services

  • Clinical Trial Services

  • Clinical Trial Audit and Monitoring

  • Non-clinical Services

  • Pre-clinical Development and Safety

  • Toxicological Risk Assessment (PDE)

  • Safety and PV Services

  • Drug safety and pharmacovigilance

  • Aggregate Report Services/Periodic Safety Report Services

  • ICSR Services

  • Signal Detection

  • Literature Monitoring Services

  • Periodic Benefit Risk Evaluation Report (PBRER)

  • Periodic Adverse Drug Experience Reports (PADER)

  • Quality Control

 
 
 

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