PharmaLex’s organization ensures global delivery of all Pharmacovigilance audit services. We are the first-choice provider of Pharmacovigilance audits for many pharmaceutical companies around the world. At PharmaLex, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.
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Our Pharmacovigilance Audit Services
PharmaLex offers a full range of Pharmacovigilance audits services in line with GVP requirements and global regulations. Our team accompanies you from the designing and implementation of PV audit system to follow-up activities and support in case of inspections.
Design and implentation of PV audit system:
- Support for defining and implementing risk-based audit strategy
- PV audit risk analysis
- Preparation and management of PV audit program
- Preparation and management of PV audit questionnaire
PV audit support:
- PV system GAP analysis
- PV audits at or on behalf of client company:
- PV System internal audits
- Affiliate audits
- License partner/distributor audits
- Qualification of PV vendor audits
- Process audits (PSMF, RMP, PSUR…)
- Due diligences
- PV inspections support
- Preparation, management and follow-up of CAPA plan related to PV audits or inspections
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Effectiveness with confidence, compliance and flexible solutions
To comply with the legislation applied to our global Pharmacovigilance (PV) market, the Marketing Authorisation Holder of medicinal products must have a PV system in compliance with all applicable regulations. PV audits are meant to review the existing PV system and to establish its compliance with regulatory PV obligations. PharmaLex has key competence in implementation of PV audit systems, CAPA management and PV inspection support. Our team can help you to verify the effectiveness of the implementation of your PV and quality systems.
Customized Pharmacovigilance Audits
PharmaLex has a wide-ranging pharmacovigilance compliance experience to accommodate the very different needs for pharmaceutical and medical device companies. Our auditing team studies the organizational structures of your company, portfolio, legal requirements and agreements to personalise all PV audit service and tailor to your needs. PharmaLex has technical set-up, know-how and great experience for remote auditing. Our aim is to conduct the audit in a way that allows you to move forward in every interaction. We offer onsite and remote audit according to your preferences.
Clinical Trials Adverse Event Processing
Clinical trials play a crucial part in any drug development life cycle where it is key to gain information on a product’s safety profile. The PharmaLex international team of clinical safety experts, with large expierence in the management of clinical safety activities, effectively supports sponsors with Pharmacovigilance activities during clinical trial development programmes. PharmaLex designs …More Info
Gap Analysis and Consulting
Place your Pharmacovigilance, Epidemiology, and Risk management activities (PER) in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire PER processes – our knowledgeable experts will be there for you no matter where you are.More Info
The collection and processing of ICSRs are the most basic and important aspects of Pharmacovigilance system. PharmaLex delivers end-to-end ICSR Management solutions through our experts and services. Contact our specialists to tailor a service plan Contact Us ICSR (Individual Safety Case Report) Management PharmaLex offer the full range of ICSR Management Services from collection, triage, …More Info
We offer a modular, end-to-end approach to literature surveillance for pharmacovigilance and our experts are flexible enough to offer a tailored solution as well accordingly to client’s requirement.More Info
Monitoring and Signal Detection
PharmaLex customizes the signal management activities as per client requirements ensuring reliable, high quality, trackable data in compliance with the regulatory guidelines (e.g., GVP Module IX & FDA Good Pharmacovigilance Practice and Pharmacoepidemiologic Assessment). In addition to Signal management services, our team of experts are also experienced and well versed in providing responses to safety questions from the Health authorities by providing strategic advice on the approach to respond to the HA query; evaluating and critically appraising ICSRs, aggregate data, and literature and thereby providing a comprehensive evaluation report considering the strengths and weaknesses of all the data sets and sources reviewed.More Info
Qualified Person for Pharmacovigilance (QPPV)
If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness.More Info
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