Drug Safety and Pharmacovigilance

Pharmaceutical companies must move to a more efficient, strategically focused PV capability in order to be less reactionary, resource-intensive, and transaction focused, and become instead a more proactive agent for patient safety.

Our core capabilities include :

  • Adverse Event Case Management including expedited reporting
  • Aggregate Reporting
  • Signal Intelligence
  • Risk Management

Comprehensive Management of ICSRs

Managing your individual case safety reports (ICSR's) accurately and efficiently is critical to an effective PV system. Our consultants provide full support for each step of the ICSR handling process. From confirmation and translations to data entry and archival, we'll manage your safety data and meet all your ICSR requirements. Our capabilities include MedDRA coding, case assessment, and electronic reporting through EudraVigilance.

Aggregate Safety Reports

We can handle all your Aggregate Safety Reporting obligations throughout the life-cycle of your product with the creation of Development Safety Update Reports (DSURs) , Periodic Benefit Risk Evaluation Report (PBRERs) and Periodic Safety Update Reports (PSURs). From compiling your DSUR information to preparing your PSUR, PBRER for the EMA (European Medicines Agency), we have the knowledge and expertise you need to stay compliant with requirements.

Pharmacovigilance Signal Management

From keeping tabs on adverse events in EudraVigilance to helping your organization follow Good Pharmacovigilance Practices (GVP), our team members will help you follow the right regulatory guidelines.

Risk management

An effective Risk Management System and the development and update of Risk Management Plans, mandatory in the EU, are a critical part of pharmacovigilance and patient safety. If you don't effectively monitor for Important Identified and Potential Risks or missing information your Marketing Authorization or Application is itself at risk.

Our in-house risk management expertise can identify new safety concerns and propose appropriate risk minimization measures, keeping you compliant and improving patient safety.

Whatever your pharmacovigilance needs, our experts can advise, implement and continue to minimize your risks and keep you fully compliant.

Regulatory Affairs

Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements. Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences. Our consulting caters to a small scale pharmaceutical looking to expand its horizon, or you need guidance for OTC authorization.

From preparing and maintaining dossiers to providing translation services, our experts make sure our clients can achieve their goals.

Pharmaceutical Validation

Qualigence Health delivers top-quality validation solutions and remains core focus of our Professional Services consulting division, which serves the pharmaceutical, medical device, biotech, animal health, cosmetic, and tissue industries.

Qualigence Health consultants strive daily to provide superior service and support in a consistent, cost-effective manner. Our ongoing investments in training, research, and technology ensure that our colleagues remain at the top of the industry, and we remain resolutely committed to living up to our reputation for excellence. From small projects to major, long-term remediation engagements, Qualigence stands behind each and every solution we deliver — and our wide range of specialties enables us to serve as an end-to-end regulatory compliance partner to our valued clients.

Areas of Specialty

  • Computer System Validation
  • Process Validation
  • Equipment Qualification
  • Cleaning Validation
  • IT Infrastructure Qualification
  • Facility/Utility Commissioning and Qualification
  • Analytical and Microbiological Methods Validation

Specific Service Offerings

  • Validation Program Development
  • Validation Planning
  • Vendor Auditing
  • Risk Assessment and Mitigation
  • User Requirements Gathering and Documentation
  • System Design Documentation (FRS, DS)
  • Qualification Protocol (IQ, OQ, PQ) Development
  • Qualification Protocol Execution
  • Validation Reporting
  • Traceability Matrices
  • SOP Development and Review
  • Validation Project Management
  • Validation Gap Analysis and Remediation