Overview

Periodic improvements of safety monitoring regulations pose a great challenge for companies to align their compliance processes with the updated regulatory standards. Maintaining the safety data of medicinal product/device is the ultimate responsibility of Marketing Authorization Holder (MAH) in order to ensure the timely submissions to health authorities and renew the product registrations globally. In a case where adverse events are reported, the process undergoes multiple steps including case triage, case processing, medical review, submission as ICSR; it is then pooled and evaluated as part of aggregate documents like benefit-risk evaluation, signal evaluation, risk management, etc.

Increased complexities, huge data, and evolving Regulatory standards have ensured that the cost of compliance in the field of drug safety is high. There arises a need of streamlined Pharmacovigilance (PV) services.

Freyr’s Safety services team consists of skilled and experienced PV professionals (both medical and paramedical) from Pharmaceutical and Clinical Research industry. With the proven expertise in delivering high quality and compliant PV services for global large pharmaceutical and leading biotech companies, the team can deliver on the PV requirements for companies of any size. The team has expertise in authoring content, coordinating reviews, performing the quality check, and project management of Pharmacovigilance activities. The team also has extensive experience in Pharmacovigilance systems and process audits, harmonization, remediation activities, the creation of CSI, CCDS and providing standalone QPPV services.

 

Freyr Capabilities

Strategy & Consulting Services

  • Gap analysis
  • Safety due diligence in mergers and acquisitions scenarios
  • Safety strategy for new markets / new products
  • Setting up of safety systems
  • Safety audits
  • Inspection preparation
  • Support for remediation activities

 

Risk Management

Risk Management Plan (RMP)

  • Drafting RMP
  • Coordination of review with stakeholders
  • Quality check
  • Finalization and publishing
 

Risk Evaluation and Mitigation Strategy (REMS)

  • Creation of REMS
  • Execution
  • REMS compliance and audits

Signal Detection

  • Data analytics
  • Signal identification
  • Literature review
  • Signal evaluation
  • Medical review

 

Safety Operations Management

Individual Case Safety Report (ICSR)

  • Setting up of operations
  • Medical Information/PV call centre
  • Receipt, triage and case allotment
  • Follow-up and case closures
  • Submission to Health Authority
  • Adherence to SLA and regulatory timelines
 

Aggregate Reports

  • Creation/Maintenance of timetable
  • Resource allocation
  • Tracking and managing preparation of reports
  • Document Level Publishing
  • Submission to Health Authority
  • Compliance to Health Authority timelines

Safety Content Services

ICSR – Spontaneous/ Literature/Clinical Trials

  • Data entry/case processing
  • Narrative writing
  • Causality assessment
  • Medical Review
  • Quality check
 

Aggregate Reports

  • Drafting of Core Data Sheet/ Core Safety Information
  • Drafting of PBRERs/PADERs/DSURs
  • Addendum to Clinical Overview
  • Coordination of review
  • Quality check
  • Medical Review
  • Finalization

 

QPPV Services

  • Setting up of Pharmacovigilance systems
  • Training of Stakeholders
  • Medical review of reports
  • Submissions
  • Safety audits and inspections

Safety Information Management

  • Process automation
  • Validation
  • Transfer of data
  • Compliance

 

Quality Control Capabilities

  • Manual and electronic proof-reading
  • Content review with various source documents
  • Medical review of the documents

 

Publishing & Document Editing

  • Document editing
  • Document level publishing

 

Technology Services

  • Document repository: To store and archive the regulatory documents.
  • Document manager: To help in assigning for parallel cross-functional review, tracking the status of various milestones (e.g. writing, review, approval etc.) for the documents during its lifecycle
 

Freyr Advantages

  • In-depth Regulatory knowledge perfectly integrated with IT capabilities
  • Expertise in ICSR case management including case triage, case processing, narrative writing, medical review, quality control and submission
  • Expertise in writing aggregate safety documents as per various agency and submission requirements like PSURs, PBRERs, DSURs, RMPs, PADERs, ASRs, any other country specific reports, etc.
  • Complete understanding of the complex drug development process, including NCEs, generics, biologics and biosimilars
  • Hands-on experience with standard and customized safety databases like Argus, ArisGlobal, TrackWise, Oracle AERS, etc.
  • Expertise in setting up PV systems, writing SOPs and training of employees as local regulatory requirements in various geographies
  • Experience in conducting mock audits, training on facing inspections, support in preparing CAPA and remediation activities
  • Extensive experience in PV process harmonization and creation of CCDS and CSI
  • Experience in tracking safety variations and PSMF compliance
  • Understanding of information management of safety and regulatory data with hands-on experience in implementing XEVMPD and upcoming standards like IDMP
  • Defined processes of thorough scientific, medical, editorial and quality control review
  • Timely delivery with the highest standard of quality
  • Expert program and project management support to maintain compliance
 

High Quality, Error Free Documents for Global Top 20 Pharma Company

Freyr helps a global client with fast-track Preparation of Protocols, Protocol Amendments, IBs, and CSRs in stringent timelines providing significant cost benefits.
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CLIENT TESTIMONIALS

 
  • Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!

    Senior Regulatory Associate, Worldwide Regulatory Strategy
    A leading research-based global Biopharmaceutical Company

  • On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire Freyr team for partnering in our mission to serve patients.

    - Director, Supplier Performance Management, Global Regulatory Affairs & Safety
    Forbes Global Top 10 Biopharma Company

  • Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.

    We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.

    – Program Manager, Regulatory Affairs – Global $1Bn Pharma Company

  • Thanks for the great work you are doing, sharing the great principles that Freyr uses for its employees and your focus on sustainability.

    – Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company