Pharmaceutical Medical Safety Writing

Medical Safety & Writing

Helping pharmaceutical and biotech clients follow the safety profile of their product, understand the benefit risk assessment, and meet global regulatory requirements

In a fast-paced industry of changing regulations and increasing drug safety demands, UBC’s drug safety and pharmacovigilance team provides insights and experience in harmonizing content and format of regulatory reports to meet requirements in the global landscape.

UBC Knows

Your product needs rational and scalable pharmacovigilance methodologies and infrastructure.  UBC’s dedicated global safety writing team has the necessary experience.  All of our safety writers are healthcare professionals with extensive pharmacovigilance regulatory experience and individual case assessment expertise.  UBC’s focus is on quality:  we have solid processes for document preparation, quality control, and consistency check.

Our capabilities include:

  • Extensive experience in thorough and accurate reports that meet regulatory requirements:

    • Periodic safety update reports (PSURs) and Periodic benefit risk evaluation reports (PBRER)
    • Development of safety update reports (DSURs)
    • Periodic adverse drug experience report (PADER)
    • Risk Management Plans
    • Benefit Risk Assessments
  • Quality control and consistency check of all safety documents
  • Safety sections of the common technical document (CTD) and investigator brochure
  • Expert statements
  • Risk or signal analysis documents
  • Responses to competent authorities

UBC Understands

Close collaboration with our clients is the surest way to develop processes and systems to achieve objectives.  Our strategy of teamwork and shared expertise allows for:

  • Flexibility – we can adjust to changing timelines and expedited needs
  • Cultural proximity – our experts in the field maintain strong contact with shifting regulatory requirements
  • Strong communication – our team of experts work with internal and external stakeholders to ensure alignment
  • Complete knowledge of client’s product – understanding requirements is the first step in developing an effective and streamlined approach for compliance
  • Efficiency – UBC’s safety writing team is composed of highly trained safety scientists and safety physicians, working in close collaboration.  UBC is committed to adjusting the team’s skill set to your document or project and to striving for the most efficient process for delivering quality on time.

Commitment to Success

UBC’s experience in pharmacovigilance is being recognized. 

  • Our services have grown 150% over the last year, thanks to repeat customers and new business.
  • Client audits and regulatory inspection of our deliverables to clients have resulted in no findings.

Contact Us

Put UBCs drug safety and pharmacovigilance team to work for your product. Contact us today.

 

Thought Leadership

Article: Preparing for safety issues following drug approval: pre-approval risk management considerations

Outsourcing Pharmacovigilance Services: Models for Big and Small Pharma

Effect of general symptom level, specific adverse events, treatment patterns, and patient characteristics on health-related quality of life in patients with multiple myeloma: results of a European, multicenter cohort study

Brochures

Pharmacovigilance, Risk Management, Signal Detection and Management

Database Analytics Automation

UBC Solutions