One Stop Shop – PharSafer® – Global Clinical and Post Marketing Drug Safety

Welcome to The One Stop Shop

At PharSafer®, we offer a comprehensive range of services tailored to meet your compliance needs. To begin your journey towards enhanced compliance, please select the service areas you are most interested in. Each category contains a variety of services designed to ensure your organization meets regulatory standards and maintains the highest levels of safety and efficiency.

We're here to support you every step of the way. Start now and take the first step towards enhanced compliance and operational excellence!

Select Your Areas of Interest *

Pharmacovigilance
Regulatory Strategy
Training
Audits
Medical Affairs
Informatics

Choose from our business sectors to explore the specific services we offer. Not sure on which option to choose? Why not visit our Services for more information?

Outline Your Product Type *

Medicines
Cosmetics
Medical Devices
Vaccines
Other

Specify the type of product you are working with, as this will determine the safety activities we will perform.

Other Product Type *

Please specify your additional product type.

Pharmacovigilance - Select Your Desired Services

Choose from our comprehensive range of pharmacovigilance services to help us understand your safety requirements. Please select all that apply.
Note that all services shown may not be relevant to your specific needs.

Regulatory Strategy - Select Your Desired Services

Choose from our comprehensive range of regulatory strategy services to help us understand your safety requirements. Please select all that apply.
Note that all services shown may not be relevant to your specific needs.

Training - Select Your Desired Services

Choose from our comprehensive range of training services to help us understand your safety requirements. Please select all that apply.
Note that all services shown may not be relevant to your specific needs.

Audits - Select Your Desired Services

Choose from our comprehensive range of audit services to help us understand your safety requirements. Please select all that apply.
Note that all services shown may not be relevant to your specific needs.

Medical Affairs - Select Your Desired Services

Choose from our comprehensive range of medical affairs services to help us understand your safety requirements. Please select all that apply.
Note that all services shown may not be relevant to your specific needs.

Informatics - Select Your Desired Services

Choose from our comprehensive range of informatics services to help us understand your safety requirements. Please select all that apply.
Note that all services shown may not be relevant to your specific needs.

Pre-Clinical Activities

Pre-Clinical Requirements – Global Strategy
Pre-Clinical Reports
Pre-Clinical Safety Assessments
Pre-Clinical Expert Reports
Interpreting Pre-Clinical Literature Articles
Pre-Clinical (Developmental) RMP/DCSI Inclusions
Human Risk Assessments

Pre-Clinical Requirements – Global Strategy Extras

Preparation
Review

Pre-Clinical Reports Extras

Preparation
Review

Pre-Clinical Safety Assessments Extras

Preparation
Review

Pre-Clinical Expert Reports Extras

Preparation
Review

Interpreting Pre-Clinical Literature Articles Extras

Preparation
Review

Pre-Clinical (Developmental) RMP/DCSI Inclusions Extras

Preparation
Review

Human Risk Assessments Extras

Preparation
Review

Clinical Trial Activities

Safety Monitoring Plan
Writing Safety Sections for Investigator Brochure (IB)
Medical Monitoring Including 24/7 Cover
Writing Integrated Summaries of Safety (ISS)
Safety Reporting Plans for Clinical trials
Developmental Core Safety Information (DCSI)
Preparing Safety Data for Independent Data Monitoring Committee (IDMC/DSMB)
SAE Case Record Form Design
Pregnancy Case Record Form Design
Investigator Training
Protocol Reviews
Reconciling SAEs with the Clinical Trials Database
Routine (monthly) reconciliations for SAE receipt

If you are interested in any Clinical Trial Activities services, please also review the review the Periodic Reporting section.

Safety Monitoring Plan Extras

SMP Writing (initial document creation)
SMP Maintenance

Writing Safety Sections for Investigator Brochure (IB) Extras

New Safety Sections for IB
IB Safety Sections updates (maintenance)

Medical Monitoring Including 24/7 Cover Extras

Telephone Line Set-up
Telephone Line Hosting
Telephone Line Maintenance

Writing Integrated Summaries of Safety (ISS) Extras

Writing
Review

Safety Reporting Plans for Clinical trials Extras

SRP Creation
SRP Maintenance

Developmental Core Safety Information (DCSI) Extras

DCSI Writing (initial document creation)
DCSI Maintenance

SAE Case Record Form Design Extras

SAE Form (initial document creation)
SAE Form Maintenance

Pregnancy Case Record Form Design Extras

Pregnancy Form (initial document creation)
Pregnancy Form Maintenance

Protocol Reviews Extras

Review of protocol - first version
Review of protocol amendments/updates

Case Processing - Clinical

Safety Report Processing
Safety Report Submissions

Safety Report Processing Extras

Initial report processing
Follow-up report processing
Follow-up requests to reporters
Case Discard/ Exclusions/ Deletions

Safety Report Submissions Extras

Monthly Compliance Listings
Unblinding for expedited submission
SUSAR submission to Regulatory Agency
Preparation of Analysis of Similar Events (AOSE) - required for US SUSAR submissions
SUSAR submission to Ethics Committees, IRBs and similar
SUSAR submission to Investigators/Study Sites
Other SAE/SUSAR submissions to third parties
Monthly Review of 10% Case Submissions (Part of the PS QMS)

Global Safety Report Processing

Safety Report Processing (i.e., Medicines, Drug-Device Combinations, Biologics, Advanced Therapies OTC/POM/P, Herbals)
Safety Report Submissions

Safety Report Processing Extras

Initial report processing
Follow-up report processing
Follow-up requests to reporters
Case Discard/ Exclusions/ Deletions

Safety Report Submissions Extras

Monthly Compliance Listings
ICSR submission to Regulatory Agency
ICSR submission to third parties e.g. local distributors, affiliates, partner companies etc.
Monthly Review of 10% Case Submissions (Part of the PS QMS)

Local Safety Report Processing

Local ADR Tracker
Safety Report Processing
Safety Report Submission
Local Processing Plan to document product processing and submission requirements as well as summarise all other contracted tasks and responsibilities

Local ADR Tracker Extras

Set-up
Maintenance

Safety Report Processing Extras

Initial report processing
Follow-up report processing
Follow-up requests to reporters
Case Discard/ Exclusions/ Deletions

Safety Report Submission Extras

Monthly Compliance Listings
Submission To Regulatory Agency
Other safety report submissions to third parties
Monthly Review of 10% Case Submissions (Part of the PS QMS)

Local Processing Plan Extras

Creation of Safety Reporting Plan (new document)
Safety Reporting Plan maintenance (updates)

Case Processing - Devices

Safety Report Processing
Safety Report Submission

Safety Report Processing Extras

Initial report processing
Follow-up report processing
Follow-up requests to reporters and/or manufacturer
Case Discard/ Exclusions/ Deletions

Safety Report Submission Extras

Incident submission to Regulatory Agency
Incident submission to Notified Body
Incident submission to third parties e.g. local distributors, affiliates, partner companies etc.
Serious public health-threat submission
Serious public health-threat - engagement with authorities and communications with other parties
FSCA & FSN preparation
FSCA & FSN review
FSCA & FSN submission
Monthly Compliance Listings
Monthly Review of 10% Case Submissions (Part of the PS QMS)

Case Processing - Vaccines

Safety Report Processing
Safety Report Submissions

Safety Report Processing Extras

Initial report processing
Follow-up report processing
Follow-up requests to reporters
Case Discard/ Exclusions/ Deletions

Safety Report Submissions Extras

ICSR submission to Regulatory Agency
ICSR submission to third parties e.g. local distributors, affiliates, partner companies etc.
Monthly Compliance Listings
Monthly Review of 10% Case Submissions (Part of the PS QMS)

Case Processing - Cosmetics

Cosmetic AE Tracker
Safety Report Processing
Safety Report Submissions

Cosmetic AE Tracker Extras

Set-up
Maintenance

Safety Report Processing Extras

Initial report processing
Follow-up report processing
Follow-up requests to reporters
Case Discard/ Exclusions/ Deletions

Safety Report Submissions Extras

ICSR submission to Regulatory Agency
ICSR submission to third parties e.g. local distributors, affiliates, partner companies etc.

Other case processing activities

Safety Reporting Plans by Country/Product Type to document product expedited reporting requirements
Reconciliations: safety reports with local partners, distributors; PQC with MAH etc.
Regulatory Authority ICSR Downloads - EudraVigilance
Regulatory Authority ICSR Downloads - EMA MLM
Regulatory Authority ICSR Downloads - MHRA
Regulatory Authority ICSR Downloads - DAENS (Australia)
Regulatory Authority ICSR Downloads - Other

Safety Reporting Plans Extras

Creation of Safety Reporting Plan (new document)
Safety Reporting Plan maintenance (updates)

Reconciliations Extras

Reconciliation set-up
Routine reconciliation undertaking

ICSR Downloads - EudraVigilance Extras

EudraVigilance business day checks
EudraVigilance download of cases

ICSR Downloads - EMA MLM Extras

EMA MLM business day checks
EMA MLM download of cases

ICSR Downloads - MHRA Extras

MHRA business day checks
MHRA download of cases

ICSR Downloads - DAENS Extras

DAENS routine checks
DAENS download of cases

ICSR Downloads - Other Extras

Other Regulatory Authority portal/website checks
Other Regulatory Authority portal/website download of cases

Safety Review & Signal Detection

Determination of Product Risk for Signal Review Strategy & Timings
Preparation of Safety/Signal Review Material from All Sources (Pre-Clinical Clinical Post Marketing)
Conducting Safety/Signal Reviews
Conduct of Safety/Signal Determination Meetings
Consultation with Regulatory for Label Amendments (CCSI/SPCs/Product Monograph/Package Inserts)
Advice on potential Urgent Safety Restrictions (USRs)/Emerging Safety Concerns
Determination of Changes in Benefit-Risk
Updates to REMs/RMPs Following Safety Reviews

Conduct of Safety/Signal Determination Meetings Extras

Write up of notes and recommendations from Safety Reviews

Safety Data Exchange Agreements (SDEAs)

Creation of (new) SDEAs Using PS Templates
Maintenance of existing SDEAs
Compliance Monitoring of SDEAs

Maintenance of existing SDEAs Extras

Review of SDEAs for Country Requirements
Maintenance of SDEAs i.e. annual reviews

Pharmacovigilance System Master File Inside & Outside EU

Utilisation of PS Template for EU and UK PSMFs
Set Up of The PSMF And Associated Annexes for Various Countries (e.g., EU UK)
Maintenance of the PSMF & Annexes as Per Agreed Schedule Built Upon Risk Assessments
Review (only) of a EU or UK PSMF

Qualified Person for Pharmacovigilance Roles

EU QPPV
National QPs for Pharmacovigilance (EU)
National QPs for Pharmacovigilance (ROW)
National Contact Person for PV
Local QP PV Including Determination of Professional/Legislative Country Requirement

EU QPPV Extras

EU QPPV (primary)
EU QPPV (deputy)

National QPs for Pharmacovigilance (EU) Extras

National QPPV (primary)
National QPPV (deputy)

National QPs for Pharmacovigilance (ROW) Extras

National QPPV (primary)
National QPPV (deputy)

Regulatory Intelligence

Regulatory Intelligence

Regulatory Intelligence Extras

Set up of Client Specific Requirements for Regulatory Intelligence
Monthly Regulatory Intelligence Checks and Notification of Findings

Periodic Reporting

DSUR
Six-month SAE listings
PBRER
PADER
PSUR
eCTD Formatting
Submission of Periodic Reports to Regulatory Agencies
Safety Reporting Plan for Periodic Reports
Determination of Changes in Benefit-Risk

DSUR Extras

Full authoring and review
Review only - of report produced by client

Six-month SAE listings Extras

Full authoring and review
Review only - of report produced by client

PBRER Extras

Full authoring and review
Review only - of report produced by client

PADER Extras

Full authoring and review
Review only - of report produced by client

PSUR Extras

Full authoring and review
Review only - of report produced by client

Safety Reporting Plan for Periodic Reports Extras

Design/ Set-up
Maintenance

Risk Management Plans (RMPs)/ Risk Evaluation & Mitigation

RMPs
REMs
Supportive Information for RMP/REMs Activities
Updates to the RMP/REMs
The ‘Global or Core’ RMP

RMPs Extras

Writing RMPs
Review of RMPs

REMs Extras

Writing RMPs
Review of RMPs

Updates to the RMP/REMs Extras

Writing Updates to the RMP/REMs
Review of Updates to the RMP/REMs

The ‘Global or Core’ RMP Extras

Writing
Review

SOP Writing

Standard Operating Procedures (SOP) and Working Practice Documents (WPD): for client departmental use and/or client-specific documentation of activities undertaken by PharSafer for client contract

SOP and WPD Extras

Writing SOPs/WPDs (initial document creation)
Maintenance of SOPs/WPDs e.g. biennial and ad hoc updates
Training on SOPs/WPDs

Literature Searching

Literature searching: global searches
Literature searching: single searches (global) i.e. for retrospective searches, specific safety issue investigations where required etc.
Local Literature Searching
Summary and Analysis
Article Ordering

Literature searching: global searches Extras

Literature Case processing Initial
Literature Case processing Follow-up
Initial set-up of product search
Maintenance/ad hoc updates of searches
Literature Search Execution (weekly search run)
Screening and Selection of Literature Articles
Review of Literature Reports/Articles for Periodic Reports
Ordering of Literature Reports/Articles for Periodic Reports
Review of Literature Reports/Articles for Signal Detection Reports
Ordering of Literature Reports/Articles for Signal Detection Reports
Quality Review of 5% Rejected Literature Hits for 50% of Each Client’s Products (Part of the PS QMS)

Literature searching: single searches (global) Extras

Set-up of product search
Literature Search Execution
Screening and Selection of Literature Articles

Local Literature Searching Extras

Undertaking annual assessment of local literature searching requirements per territory
Implementing local literature search requirements
Monthly local literature search reviews, including QC stage
Local journal subscription fees (if applicable)

Article Ordering Extras

Article ordering
Article cost (if applicable)
Article / abstract translation (if applicable)

Licencing

Regulatory Strategy for Licence Production, Scientific Advice & Submissions
Global Licence Submissions
Licence Variations
Licence Renewals/Extensions
Due Diligence for Licence Acquisitions

Regulatory Strategy for Licence Production, Scientific Advice & Submissions Extras

Preparation of regulatory strategy
Review of regulatory strategy

Due Diligence for Licence Acquisitions Extras

Carry out Due Diligence investigations, prepare reports
Review of Due Diligence reports

Via PharSafer® Sister Company SaPhar Training®

Beginner, Intermediate or Advanced Training Courses
Clinical Safety Training
Bespoke training
Training of partners/distributors/sales representatives/other departments

Auditing

‘Fit for Purpose’ Audit - Caveat Emptor
Pharmacovigilance Audits of Partners/Affiliates/Headquarters
Pharmacovigilance Audits of Distributors/PSPs/Providers/Market Research
Risk Assessment Questionnaires for Pharmacovigilance Audits
GPV Audits
GCP Audits
IT Validation
Gap-Fill Analyses
Due Diligence Activities (Company/Product Purchases/Mergers)

Quality Management System (QMS)

QMS Design and Assessment

Audit Preparedness

Pre-Audit Risk Assessments
Post Audit Activity - Corrective and Preventative Action (CAPA) Review
Inspection Preparation/Conduct/CAPA Resolution

Storage & Archive

Annual Secure Storage and Archive of Paper and Electronic Data

Medical Information

Medical Information Enquiries
Set-up and Maintenance of Frequently Asked Questions (FAQs)
Review and Sign Off of Master Promotional Material (Global Message Claims Verification)
Educational Material Approval
Competitor Analyses
Monthly QC of Medical Information Enquiries

Medical Information Enquiries Extras

Set-up dedicated telephone line
Set-up of translation service (if required)
Provision of 24/7 Cover for Answering Medical Enquiries
Production of MIE tracker (Free of Charge)
Responding to Medical Enquiries
Documenting & forwarding safety reports (AE, SSR, incident etc.)
Documenting & forwarding product quality complaints (PQCs)
Monthly enquiry reconciliation activities
Telephone Hosting
Telephone line maintenance

Safety Database

Safety Database Selection
Safety Database Rental
Safety Data Migrations
Periodic Report Submissions – Database Set-Up

EudraVigilance & Worldwide Electronic ICSR & Product Reporting

EudraVigilance
MHRA
FDA
Other regulatory electronic reporting platforms
XEVMPDs

Automated Case Processing – Rapid Automated Processing & Tracking of Adverse Reactions (R.A.P.T.A.R®)

R.A.P.T.A.R® Reporting
R.A.P.T.A.R® Clinical
R.A.P.T.A.R® Reader

Safety Database Selection Extras

Safety Database Client Installation
Safety Database Implementation for the Company
Validation Document Review

EudraVigilance Extras

Set-Up
Maintenance

MHRA Extras

Set-Up
Maintenance

FDA Extras

Set-Up
Maintenance

Safety Database Rental Extras

Safety Database Read Only Access
Safety Database Write Access
Safety Database Maintenance
Safety Database Upgrades
Product Dictionary Database Set-Up
Product Dictionary Database Maintenance
Training On Safety Database
MedDRA Licence Updates (Obligatory)
Expedited Reporting Set Up And Maintenance

Other regulatory electronic reporting platforms Extras

Set-Up
Maintenance

XEVMPDs Extras

Insert
Updates
Invalidation
Nullification

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