• Pharmacovigilance
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Regulatory Affairs is an area of rapid change and ever increasing complexity. Healthcare and life science companies need to work smarter than ever before. Regulatory outsourcing is a key strategy that assist companies to focus on their core competencies and innovations. At HERMS, we understand the regulatory process and can support your product to approval and commercialization. From general compliance issues, reporting requirements and product dossier submissions, HERMS has the expertise to help manufacturers navigate the often confusing regulations, policies, guidelines, and practices in an ever changing regulatory environment. HERMS ability to assess issues and provide strategic planning is efficient and unique. In serving clients’ needs we add value to avoid high costs and irreversible mistakes. When submitting marketing authorization application, HERMS focuses on achieving registration and commercialization in a timely manner. Our focus considers your need to maintain a long term and compliant market presence. On compliance issues ,we support our clients to avoid the often times serious consequences which can arise through actions imposed by the regulators.


HERMS provides comprehensive pharmacovigilance services to assist clients in tackling these concerns with confidence.

Safety Data Management and Global Safety Database

HERMS will support you in the following: 

  • Coding of AE's
  • Clinical and patient profile review
  • Generation of reports
  • Integrated Summary for signal detection
  • Review of clinical laboratory data
  • Review and follow-up of SAE's
  • Review of concomitant medications, and AE's

Adverse Event Case Processing

We will support you in the following:

  • Adverse event evaluation and classification
  • Guidance on how, when, and where to submit
  • Preparation of adverse event case reports
  • Record maintenance for serious and non-serious adverse events
  • Procedure creation for Call Center Representatives on handling calls completing AER forms
  • Training for Call Center Representatives on handling calls and completing AER forms
  • Creation of templates for Customer Complaints

Pharmacovigilance Report Preparation

We will support you in the following:

  • Periodic Adverse Drug Experience Report (PADER)
  • Periodic Benefit Risk Evaluation Report (PBRER)
  • Periodic Safety Update Reports (PSUR)
  • Risk Management Plans (RMPs)
  • Risk Evaluation and Mitigation Plans (REMPs)
  • ADR Reporting/Monitoring Services
  • Safety Assessment Reports (SARs)
  • Safety Narratives (Brief and Full Narratives)
  • Annual Safety Reports (ASRs)

Scientific literature review for adverse events

We will support you in the following:

  • Coding of AE's
  • Clinical and Patient Profile Review
  • Generation of reports
  • Finding Literature
  • Relevancy
  • Structuring the Chapter
  • Critical Review

Medical Monitoring

We will support you in the following:

  • Performing quality checks by doing case analysis and peer reviews
  • Medical strategy and assistance in protocol and other documentation
  • Study optimization strategies, including patient recruitment approaches
  • Identification of study risks and appropriate mitigation strategies
  • Oversight of the safety of study participants, medical review of adverse events, safety listings, and interim/final trial reports
  • Assessment and evaluation of safety data, and protocol deviations
  • Looking at each medical record to check for missing documentation

Manage non-standard/off-label medical inquiries from consumers and health care providers

HERMS will support you in the following: 

  • Reporting cases of off-label use associated with suspected AE's
  • Periodic reporting of risks related to the off-label use
  • Risk management planning based on off-label use
  • Collection and follow-up of cases of off-label use
  • Benefit-risk analysis
  • Monitoring social media sites
  • Interactions with patient organizations

Pharmacovigilance Quality Assurance

We will support you in the following:

  • Preparation of Quality Manual, Policy, SOPs and Work Instructions
  • Development of process mapping for PV systems
  • Development & Management of KPIs
  • PV Audit planning, conduct and reporting
  • Development of CAPA (Corrective and Preventive Action)
  • Support for identifying advanced compliance solutions
  • PV and Quality Compliance consultancy
  • Support for PV Inspection preparation

Provide Authorized local QPPV and Deputy on behalf of the clients.

We will support you in the following:

  • Acting as the single point of contact and provide safety or any other benefit-risk evaluation responses
  • Ensure that the Pharmacovigilance System Master File (PSMF) is constantly up-to-date and correctly describes the current pharmacovigilance system
  • Overseeing the safety profiles of marketed products and any emerging safety concerns
  • Ensure that the level of all pharmacovigilance activities, and the submission of all pharmacovigilance-related documents, is in accordance with GVP practices and all other applicable legal requirements

Revision, Evaluation & Submission of Individual Case Safety Reports (ICSRs).

HERMS will support you in the following: 

  • Case Input; spontaneous cases, literature cases, clinical trial cases, and safety call centers
  • Case receipt
  • Case processing and medical review
  • Case output
  • Output analysis; PSUR compilation, and signal management benefit
  • Risk assessment
  • Cases reconciliation

Evaluation and Submission for PSURs, RMPs and PSMF

HERMS will support you in the following: 

  • Preparing periodic benefit-risk evaluation reports (PBRER) and other aggregate reports (non-EU PSURs, ACOs)
  • Writing RMPs and RMP maintenance in line with GVP requirements
  • Strategic consulting in designing risk minimization programs to meet regulatory requirements
  • Advise or perform analysis of the effectiveness of the risk minimization activities
  • Preparing Clinical Expert Statements
  • Risk-Benefit Assessment
  • Responses to authority requests

Preparation of complete set of Pharmacovigilance SOPs.

HERMS will support you in creating SOPs as follows:

  • Processing Adverse Events and SAEs
  • QPPV Role and Responsibilities
  • Complaint Processing, Literature Searches, and Aggregate Reporting
  • Manual Procedure for Handling Adverse Events
  • Signal Detection and Risk Management
  • Product Quality Complaints
  • Medical Information Enquiries

Preparation of Pharmacovigilance Quality Management System (QMS).

HERMS will support you in the following: 

  • Designing and managing a quality system related to your PV system
  • Development and maintenance of the PV system master file
  • Analyzing how the PV quality system integrates with the pharmacovigilance system
  • Development and maintenance of PV sops and PV related documents
  • Assessing the effectiveness of the quality management system
  • Defining the scope of pharmacovigilance audits, and how to prepare for audits and inspections
  • Preparing responses to a pharmacovigilance audit and inspection findings