PHARMACOVIGILANCE

  • Support for setting-up of efficient, cost effective in-house PV department/ specific PV processes
  • Preparation & Training of SOPs
  • Gap Analysis: Review of the current processes
  • Support for selective outsourcing with optimal utilization of in-house resources
  • Integration of new acquisitions/ multiple safety databases
  • Due diligence of potential/ new acquisitions/ gap analysis
  • Mock Inspections
  • CAPA preparation
  • Inspection Preparation:
  • Inspection Readiness for PV and cross functional teams
  • Customized training as per MAH requirements OR
  • Avail our dedicated training modules for learning about
  • SDEAs
  • Medical Review
  • Benefit Risk Analysis
  • Inspection Readiness
  • Authoring, regular update and maintenance of PSMF

We can partner with you for all-time inspection readiness as well as in preparing for an upcoming announced or expected inspection. We provide following services:

  • Identifying the potential areas and documents of interest as per the focus of specific regulatory authority
  • Organizing the documents for quick turnaround time for requests raised by inspectors
  • Review of SOPs to check compliance with regulations –> advise updates/ CAPAs as required
  • Process review to check compliance with SOPs –> advise updates/ CAPAs as required
  • Preparing compliance reports, summaries, tables as usually requested during inspection
  • Review of ongoing and closed CAPAs
  • Review of PSMF, where applicable
  • Preparing Presentations for inspections
  • Selection and training of Subject Matter Experts for interviews during inspection

We also provide support during inspection for successful inspection as well as after inspection in preparation of the response and planning and implementation of CAPAs.

PSMF/ PvMF:

  • PSMF forms the base of Competent Authority inspections
  • Preparation, authoring and maintenance of PSMF

QPPv services:

  • QPPv is the centre of PV inspections
  • EU QPPV & Deputy services as per GVP
  • Ensuring all requests from Regulatory Authorities are answered completely and promptly.
  • Oversight of the PV System in terms of structure & performance
  • Performance assessment as per the metrics

ICSR Processing:

  • Regulatory authorities place great importance on compliance with case processing
  • Cost effective end to end management of case processing
  • Includes case triage, data entry, quality control, MedDRA coding, medical review, reportability assessment, regulatory reporting and follow-up
  • Experienced Pharmacovigilance Physicians review all cases
  • Ensuring Compliance better than industry standards
  • High Quality Narratives
  • 100% QC check

Periodic safety Reports:

  • Experienced writers help in preparing periodic safety reports
  • Calendar management and planning of safety reports
  • Complete authoring and production as per the required format PBRERs/ PADERs/ PSURs/ ASRs/ SBRs/ Addendums
  • Authoring of DSURs
  • Quick turn-around time to meet stringent timelines

Signal Detection & Analysis:

  • Review of current signal management practices
  • Identification and Prioritization of signals from company database
  • Assess Individual case and aggregate reports for signal evaluation
  • Medical monitoring of safety signals on a monthly or quarterly basis
  • Complete work of signals including signal evaluation, literature review for epidemiological inputs and closing of signal
  • Preparation of Signal Evaluation Reports
  • Communication of Signal to Regulatory Authorities
  • Preparing DHCP communications

Risk Management Plans:

  • Required for all dossier submissions
  • Quick turn-around time for authoring and preparation of RMPs
  • Designing of Risk Minimization Measures, including websites, Educational materials, medication guides etc
  • Effectiveness analysis for RMMs with the help of Surveys and Testing

Literature Searching:

  • Weekly/ Ongoing Literature search
  • Identification & Management of safety relevant data
  • Integration with case processing and 100% reconciliation
  • PSUR Literature search and analysis

Safety Data Exchange Agreements (SDEAs):

  • Preparation of SDEAs customized per country specific regulatory requirements.
  • Review of SDEAs
  • Set up/ fine tune processes to ensure compliance with SDEAs

 Safety- Medical writing:

  • Analysis of Similar Events
  • Causality Assessments
  • Health Hazard Assessments for Recalls, FARs and trending results
  • FAQs
  • Benefit Risk Assessments
  • Integrated Safety Summary (ISS)
  • NDA Clinical Report Safety Sections
  • Clinical Overview & Clinical Summary
  • Preparation, authoring & maintenance of PSMF

Quality & Compliance:

  • Review & manage Compliance metrics for key PV activities
  • Develop & Implement Quality Management System (QMS), including preparation/ review of SOPs, Work Practices
  • Closure of inspection findings: Identify and Prioritize improvements & CAPA support

Drug Safety in Clinical Development:

  • Highly experienced and trained drug safety physicians for the management of drug safety from clinical trials.
  • 24/7/365 support by drug safety physicians for investigators
  • High quality and cost- effective services during all phases of Clinical Development

Study start up activities:

  • Input into safety sections of clinical study protocols.
  • Setup of serious adverse event reporting procedures
  • Training of the investigators and CRAs.
  • Preparation of an investigator Serious Adverse Event Manual.

Serious Adverse Event Management:

  • Initial event receipt and triage.
  • Case processing, including data entry, narrative generation, and quality.
  • MedDRA coding
  • Follow-up case processing
  • Analysis of Similar Events (AOSE)
  • Reporting of SUSARs to relevant regulatory authorities
  • Reconciliation: periodic Reconciliation of safety data received and sent.

End of Study Activities:

  • Reconciliation of SAE database with Clinical database.
  • Clinical Study Reports: Input into the safety sections of Clinical Study Reports.

 Medical Writing for Drug Safety:

  • Preparation and submission of Drug Safety Update Reports
  • Periodic Newsletter for investigator sites
  • Highly experienced and trained drug safety physicians for the management of drug safety from clinical trials.
  • 24/7/365 support by drug safety physicians for investigators
  • High quality and cost- effective services during all phases of Clinical Development

Study start up activities

  • Input into safety sections of clinical study protocols.
  • Setup of serious adverse event reporting procedures
  • Training of the investigators and CRAs.
  • Preparation of an investigator Serious Adverse Event Manual.

Serious Adverse Event Management

  • Initial event receipt and triage.
  • Case processing, including data entry, narrative generation, and quality.
  • MedDRA coding
  • Follow-up case processing
  • Analysis of Similar Events (AOSE)
  • Reporting of SUSARs to relevant regulatory authorities
  • Reconciliation: periodic Reconciliation of safety data received and sent.

End of Study Activities

  • Reconciliation of SAE database with Clinical database.
  • Clinical Study Reports: Input into the safety sections of Clinical Study Reports.

 Medical Writing for Drug Safety

  • Preparation and submission of Drug Safety Update Reports
  • Periodic Newsletter for investigator sites