Our Services

  • Book in, Triaging & 24/7/365 Case Management Support.
  • Data entry into validated electronic PV database.
  • 100% Quality control of all ICSR including medical QC.
  • Medical review and assessment, narrative writing, MedDRA coding.
  • Product Quality Complaints Management.
  • Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities.
  • Full text weekly searches from worldwide literatures.
  • Ongoing, weekly literature monitoring for identification of ICSRs (Individual Case Safety Reports).
  • Active ingredient specific - alternative names/ Product specific search.
  • Integration with case processing in safety database.
  • Full text articles procurement and translation.
  • Production of Product Specific Line Listings.
  • Complete authoring and production of PEBRERs, PADERs, SBRs, DSURs/Addendums/SBRs/Addendum to clinical Overview.
  • Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80.
  • Authoring and preparation of SDEAs customized per global regulatory requirements.
  • Review of SDEAs.
  • Negotiating safety aspects to be included in the SDEAs with business partners.
  • 24/7/365 Support with EU QPPV & DQPPV Good PV Practice Modules (GVP) - New EU PV Regulations.
  • Oversight of the PV System in terms of structure & performance to ensure appropriate collation of ADRs, preparation and sign off of regulatory documents (PSURs etc) and Post-Authorisation Safety Studies (PASS Studies).
  • Ensuring all requests from Regulatory Authorities are answered completely and promptly.
  • Review & manage Compliance metrics for ADR reporting to regulatory authorities.
  • Undertake Mock PV Audits for QPPV Office & Global PV depts.
  • Undertake GCP Audits.
  • Develop & Implement Quality Management System (QMS).
  • Support & Prepare for Inspection readiness & business partner and external audits.
  • Gap Analysis of systems & processes.
  • Identify and Prioritize improvements & CAPA support for closure of inspection findings.
  • Support with Identification and Prioritization of Signals from company databases.
  • Complete work up of signals including, signal evaluation, epidemiological input and closing of signals.
  • Authoring of Signal Evaluation Reports (SERs) or Issue Work Ups of signal for regulatory submission.
  • Communication of Signals to Regulatory Authorities and Prescribers.
  • Authoring and preparation of EU RMPs and REMS.
  • Help & Support with preparation of Medication Guides, Educational Materials and other Risk Minimisation Plans.
  • Help & Support with Survey and testing as a measure of effectiveness of RMP/REMS with patients and prescribers.
  • Preparation and authoring of labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, PILs)
  • Pharmacovigilance specific trainings for PV/Safety departments
  • Epidemiological Literature Searches & Reviews
  • Support with Study Design & protocols for studies
  • Support with PASS Studies
  • Authoring of Pharmacoepidemiological Study Reports
  • Post– Approval Safety Studies (PASS)
  • ICSR Narratives—Company Assessment & Comments
  • Causality Assessments
  • Risk Benefit Assessments
  • Analysis of Similar Events
  • Integrated Safety Summary (ISS)
  • NDA Clinical Report Safety Sections
  • Patient Profiles in Clinical Trials Study Reports
  • Preparation of Clinical Overview & Clinical Summary
  • Preparation , authoring & maintenance of PSMF
  • Phamacovigilance Plans
  • Dear Doctor & HCP Letters
  • MedDRA Coding and Data Analysis
  • Reconciliation of Clinical & Safety Databases
  • Migration of Data and Legacy data from various databases
  • Generation of CIOMS Line Listings
  • Data Mining from various databases
  • Clinical Trial Safety Support - Phase I, IIa, IIb & III
  • Preparation of Medical Management Plan
  • Preparation of Safety Management Plan
  • Preparation of Safety sections of eCTD for NDA, IND & BLA submissions
  • NDA, IND and BLA Safety Review
  • Compassionate Use Programs Support & Monitoring
  • xEVMPD Support for maintaining products on EV Database
  • Preparation of CTD Modules 1.8.1 (PSMF) & 1.8.2 (RMP)
  • Regulatory Strategy Support in Early Development, Ph. IIb—III, Post-Marketing & Lifecycle Regulatory Support
  • Preparation of eCTD regulatory dossiers

Experience

More than 18 years of experience providing Pharmacovigilance and Pharmacoepidemiology services,
our of global experts include highly qualified, trained and experienced professionals
from the corporate and academic world.

Quality

By understanding and improving operational processes; identifying customer requirements
quickly and systematically; establishing valid and reliable service performance measures
and measuring customer satisfaction.

Innovation

Research and innovation is an important part of Symogen business development process.
We focus in several research projects to continually improve and enhance the quality of our services
and to meet the high requirements of our customers.

GLobal Presence

With main offices in Europe, United States and Asia,
Symogen provides uninterrupted services 24/7/365 world wide. We are able to create specialized teams for deployment in any part of the world,
increasing the efficiency and decreasing the overall outsourcing costs of your company.