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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
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DRUG SAFETY & PHARMACOVIGILANCE SERVICES

  • 24/7/365 Case Management Support
  • Complete authoring and production of PEBRERs, PADERs, DSURs; BR Reports & Addendum to Cinical Overview (ACO)
  • Weekly Literature Search, Review & Monitoring
  • Complete oversight : Tracking; exchange, compliance, updating SDEAs & archiving through in-house STREAM database
  • 24/7/365 Support EU QPPV & Local QPPV
  • Undertake GPV; GCP & CSV Audits
  • Undertake Gap analysis of systems & processes
  • Develop & Implement Quality Management System (QMS)
  • Support Inspection readiness & external audits & CAPA
  • Gap Analysis of systems & processes
  • Complete management of signals including, signal evaluation, epidemiological input and closing of signals
  • Authoring of Signal Evaluation Reports (SERs) & Issue Work Ups of signal for regulatory submission
  • Communication of Signals to Regulatory Authorities
  • Authoring of Dear Doctor & HCP Letters
  • Authoring & preparation of Global & Local RMPs & REMS
  • Preparation of Medication Guides, Educational Materials
  • Support with Survey & testing a measure of effectiveness of RMP/REMS with patients and prescribers
  • Preparation & authoring of labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, PILs) & IFU for MDs
  • Global & Local Epidemiological Literature Searches & Reviews
  • Support with Study Design & protocols for studies
  • Support with Global & Local Post Approval Safety Studies
  • Set up & manage Global & Local Registries to support safety issues
  • Authoring of Pharmacoepidemiological Study Reports
  • ICSR Narratives—Company Causality Assessment & Comments
  • Integrated Safety Summary (ISS)
  • NDA Clinical Report Safety Sections & 2.7.4
  • Preparation of Patient Profiles in Clinical Trials Study Reports
  • Preparation of Clinical Overview & Clinical Summary
  • Preparation of Safety Signal Evaluation Reports & Trending Reports
  • Preparation of PBRERs, PADER, DSUR & ACOs for product renewals
  • Risk Management Plans (EU RMPs; REMS;: PIPs)
  • Pharmacovigilance Plans & Benefit Risk Assessment Reports
  • Labelling documents—CCDS; SmPCs;USPI; IBs & IFUs
  • Dear Doctor & HCP Letters, Handling & responding to HA requests
  • Preparation of eCTD & ACTD regulatory dossiers
  • Manuscript writing for various scientific journals and conferences
  • MedDRA Coding, Data Analysis & Reconciliation of CT & PM Databases
  • Migration of Data and Legacy data from various databases
  • Generation & Analysis of Smart CT & PM Safety Data & Line Listings
  • Signal Data Mining & Analysis: Qualitative & Quantitative; Disproportional Recording Vs Disproportional Reporting; Descriptive, Predictive & Prescriptive Modelling
  • In-depth analysis of data from multiple large databases & sources
  • Predictive & Precedence Analytics for future outcomes & safety trends
  • Support & development of Predictive Structured Benefit Risk Assessment Framework & Safety Strategy Planning from early development through life cycle management: Value Tree & Visualization Tools; Effect Table; Forest Plot; MCDA/SMMA
  • Clinical Development Safety Support - Phase I, IIa, IIb & III
  • Support with Medical Monitoring & Preparation of Safety Management Plan; Protocol development and
  • Preparation of Clinical & Safety sections of eCTD for submissions
  • Preparation of NDA, IND; BLA & respective Safety sections
  • Authoring & Preparation of ISS and Clinical Study Reports (CSRs)
  • Observational Studies; PAES & PASS
  • Provide Scientific & Clinical support for products
  • Support with product launches
  • Support to Key Opinion Leaders (KOLs)
  • Support with handling queries from HCPs & patients
  • Support brand/marketing teams with scientific information & code compliance for marketing materials, conferences & events
  • Global & Local Compassionate Use Program Support & Monitoring
  • Registries set up & management: Disease; Product; Treatment
  • From planning, developing and executing project ideas to building, leading and supporting teams
  • Support systematic approach of initiation, planning & implementation
  • Monitor projects to ensure strategic objectives are met
  • Monitor quality of projects and ensure on time completion
  • IDMP Support for maintaining products on Databases
  • Preparation /Review/Compilation of IMPD, NDA, BLAs for HAs
  • 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 & ACTD regulatory dossiers
  • Global & Local Prospective & Retrospective RWD &E services
  • Real World Evidence Patient Centered Platforms generating data from Electronic Health Records (EHR), HA databases
  • Support with EU MDR Regulations
  • Gap Analysis & Preparation of Remediation Plans
  • Preparation of Safety Summary & Clinical Performance
  • Preparation of Clinical Evaluation Plans
  • Clinical Evaluation Repors & Post Market Clinical Follow-up
  • Signal Detection Mining & Management & Trending
  • Preparation of Device Benefit Risk Assessment Reports
  • Preparation of Device Post Marketing Surveillance Plans
  • Preparation of Medical Device Risk Management Plans
  • Support with Vaccine Case processing & Submissions
  • Preparation of Vaccine Aggregate Reports
  • Vaccine Signal Detection & Management Support
  • Preparation of Signal Evaluation Reports
  • Preparation of Vaccine RMPs & Benefit Risk Reports

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With an impeccable track record of quality and highly ethical practices, Ahlyna serves global clients that include start-ups, mid-sized enterprises and fortune 100 companies.

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