Post-Marketing Pharmacovigilance

audit

Providing support on all aspects of audit and CAPA close-out. From routine PV system audits to  inspection readiness activities, affiliate or third-party PV audits, we provide an experienced eye to ensure systems are working to both company SOP and in regulatory compliance.

sops & Process Optimisation

Whether setting up a new system or looking for a 'health check' on an existing one, we provide new SOP writing services as well as GAP analysis, optimisation and implementation. 

Rather than a one-size-fits-all approach, we work closely with you to make processes compliant with regulatory requirements but, most importantly, practical and fit for your ways of working. 

SIGNAL DETECTION & RISK MANAGEMENT

Continuous signal detection pro-active risk management are vital to the maintenance of the benefit-risk profile of a product. We can develop and run your signal detection processes and author, implement and maintain risk management plans.

Safety Database

Set-up and configuration of safety databases, migration of legacy cases and continuous oversight and management. We can support existing systems or provide a database directly from a trusted partner.

eudravigilance & Article 57

Certified user of the R3 compliant Eudravigilance database, including EVDAS experience, and Article 57 database. We can set up, manage and maintain your Eudravigilance activities, or provide additional support and training to your users.

psmf

Possibly the most important PV document for MAHs in Europe, we can author and maintain for our clients Pharmacovigilance System Master File (PSMF), ensuring constant readiness in the event of a request from a competent authority. 

sdeas

With ever more complex interactions between organisations involved in the development and delivery of pharmaceutical products, it is vital that every party is clear on their PV responsibilities. We author, review, implement and maintain agreements, to ensure our clients retain robust safety data collection processes.

Training

GVP training for PV groups and non-PV staff. In addition we passionately believe that patient safety is a company-wide activity and provide cross-functional training to optimise PV processes.

qppv

We can provide 24 hour EU-QPPV, or deputy, services to meet regulatory requirements and maintain oversight of the PV system of the Marketing Authorisation Holder (MAH).

Please speak to us about your local-QPPV needs too.

periodic reports

Extensive experience in authoring and submitting PSURs/PBRERs to global authorities. Full document development, including QC and medical review, or ad hoc support with specific sections, or workload peaks, available,  

literature screening

We provide global literature searching for routine adverse drug reaction identification, as well as periodic reports and signal detection and validation activities. From designing and validating search strategies to conducting weekly searches, we provide effective and efficient solutions to this labour intensive activity.