18
Years in Business
Enjoy all the benefits of
working with Symogen
Full-Scale solutions for your Pharmacovigilance requirements throughout clinical trials phases, as well as post-marketing processes covering high-quality data collection, assessment and reporting.
- Pharmacovigilance
- Medical Device Vigilance
- Medical Writing
- Regulatory Strategy
- Quality Assurance
Over 50+ Satisfied clients & Still counting
99
% ICSRS
100
% Aggregate Reports
190000
Cases Yearly
Our Services
Pharmacovigilance Services - Clinical and Post-Marketing
- Book in, Triaging & 24/7 Case & Incident Management Support
- Full data entry into validated Safety Database (ARGUS, ARISG)
- 100% Quality control of all ICSR & Incident Reports
- Medical review & assessment, narrative writing, MedDRA coding
- Product Quality Complaints Management
- Reporting /Submissions: Electronic (E2B), to worldwide RA
- Full text weekly searches & analysis from databases
- Integration with case processing in safety database
- Full text articles procurement and translation
- Production of Product Specific Line Listings for aggregate data analysis
- Complete authoring and production of PEBRERs, PADERs, DSURs; BRs/Addendum to clinical Overview (ACO)
- Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80; EU MDR including MEDDEV 2.7.1 Rev 4
- Preparation of SDEAs customized per global regulatory requirements including SOPs
- Complete oversight: Tracking; exchange, compliance, updating SDEAs & archiving through in-house STREAM database
- In-house Web based Safety Data Exchange platform, “STREAM
- Negotiating safety aspects to be included in the SDEAs with business partners
- 24/7/365 Support EU QPPV - Good PV Practice Modules (GVP) & EU MDR Act as single point of contact
- Oversight of the PV System: structure & performance to ensure appropriate collation of ADRs, preparation and sign off of regulatory documents (PBRERs etc.) and PASS Studies
- Ensure all requests from Regulatory Authorities are answered completely and promptly
- Preparation and creating labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, USPI, PILs)
- Review & manage Compliance metrics for ADR & Incident reports to regulatory authorities worldwide
- Undertake Mock Audits for Local PV, Global PV & Medical device departments
- Develop & Implement Quality Management System (QMS)
- Support & Prepare for Inspection readiness & business partner external audits
Medical Device Vigilance & EU MDR
- Support with end to end Incident Report Management (IRM) including: Incident processing, Medical Review, QC & Submission.
- Handling Quality Complaints with & without safety incidents in USA, EU & worldwide.
-
Create CER as per MEDDEV 2.7.1 Rev 4 including annual updates to all reports:
- Structured literature search, review and analysis.
- Risk Benefit Assessment.
- Equivalency approach.
- Post Market Surveillance Data Analysis including Trend CER: Analysis, Non-Clinical/Clinical Data (bench, pre-clinical, sponsored studies/IIR & State of the Art
- Support & create Post Marketing Surveillance Plan (PMS).
- Support & create Post Marketing Clinical Follow-up Plan (PMCF) & Initial Report.
- Support & create PSURs for Class II a & b and Class III devices.
- Support & create Summary of Safety and Clinical Performance (SSCP).
- Support & creation of Signal Detection and Incident Signal Evaluation Reports.
- Support & create Risk Management Plans including Benefit Risk Assessment.
- Support with end to end Incident Report Management (IRM) including: Incident processing, Medical Review, QC & Submission.
- Handling Quality Complaints with & without safety incidents in USA, EU & worldwide.
- Review of technical files & data to conduct effective gap and analysis.
- Support and provide remediation plan for the gaps and address compliance.
- Support full service clinical evidence programs from advisory to implementation.
- Support with Retrospective/ EMR data, Surveys, Literature and Registries set up.
- Supporting Regulatory Strategy for Class I, II a & b & Class III.
Medical Writing Services
- Production of Product Specific Line Listings.
- Complete authoring and production of PEBRERs/PSURs, PADERs, DSURs, Addendum to Clinical Overview (ACO).
- Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80.
- ICSR Narratives—Company Assessment & Comments
- Causality Assessments
- Risk Benefit Assessments
- Analysis of Similar Events
- Integrated Safety Summary (ISS)
- Preparation of Clinical Study Reports (CSR)
- NDA Clinical Report Safety Sections
- Patient Profiles for Different Phases
- Preparation of Clinical Overview & Clinical Summary
- Preparation , authoring & maintenance of PSMF
- Phamacovigilance Plans
- Dear Doctor & HCP Letters
- 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.
Pharmaceutical Early Drug Development Services
- Clinical Development Safety Support - Phase I, IIa, IIb & III
- Preparation of Safety Management Plan; Medical Monitoring
- Preparation of Safety sections of eCTD for submissions
- Preparation of NDA, IND and BLA Safety sections
- Authoring of ISS and Clinical Study Reports (CSRs)
Safety Database Solutions
- A cloud based, an integrated end-to-end safety platform supporting case management
- Inbuilt reporting metrics and compliance module within safety database
- Import and export both R2 and R3 E2B files
- Scalable and customizable safety solution for safety case processing
- Integrated BI solution
- Integrated Workflow
- Integrated Gateway e.g. EMA, FDA
Quality Assurance Services
- 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.
Pharmacoepidemiology Services
- 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)
Benefits-Risk Management Service
- 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.
Regulatory Strategy Help Services
- 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
Become Symogen's Partner
With an impeccable track record of quality and highly ethical practices, Symogen serves global clients that include start-ups, mid-sized enterprises and fortune 100 companies.
Contact US