Drug Safety and Pharmacovigilance

Regulatory agencies worldwide enforce strict guidelines to address the safety of the consumer. Biopharma and Medical Device companies are being put under the scanner to abide by them.

We provide a full spectrum of drug safety/ pharmacovigilance consulting, solutions and services in accordance with regulatory requirements with 24/7/365 availability.

Our physicians, pharmacists & safety executives are experienced in medical safety, adverse event management, capturing & reporting of the safety data in drugs, biologics, & medical devices.

Adverse Event Management Services

• AE case processing—case intake, triage, medical coding & narrative writing
• Emergency assessment, treatment advice, and triage recommendations.
• Follow-up to assess progress
• Comprehensive documentation of events surrounding the exposure
• Assessment for severity and consistency

Periodic Safety Update Reports

• Completed 3500A forms for PSUR submissions.
• Adverse events previously reported as 15-day alert reports during the reporting period
• Serious events not meeting the 15-day alert reporting requirements & reporting period
• Literature search

Expertise

• Dedicated safety and medical information call center
• Generic products AE reportingand labeling challenges
• Identify intended and unintended usage that may contribute to unintended effects
• Assess product safety when used by itself or in presence of other products or substances
• Adverse Data entry and management in off site or remote access locations to the client

Risk Evaluation & Mitigation Strategies (REMS)

Pharmcentre develops risk evaluation and mitigation strategies (REMS) to support drug, device and consumer health organizations worldwide

We offer consultancy, solutions and services for review and development of proposed REMS as well as REMS supporting documentation

Services:

• Assessment strategies.
• REMS goals including communication plans, information materials
• Elements to Assure Safe Use (ETASU)
• Risk management strategies in prescriber/patient education
• Risk management strategies specialized patient support and monitoring

Expertise:

• Development of REMS and Assessment Strategies (surveys, etc.)
• Risk management plans review before subsequent to new PSUR findings
• Harmonization activities between EU RMP and US REMS
• Assistance with development & implementation of EU RMP