Medwork

Services

Safety

Medwork is dedicated to supporting marketing authorization holders and medical device manufacturers in fulfilling their vigilance obligations. With 20 years of experience across various aspects of vigilance, our team possesses a wealth of knowledge and a comprehensive understanding of the complexities involved in ensuring the safety of medicines and medical devices.

PV SYSTEMS & QPPV SERVICES

We establish and maintain robust pharmacovigilance systems. Our team of experienced EU Qualified Persons for Pharmacovigilance guarantees the effective management of your drug safety affairs and ensures strict regulatory compliance.

LOCAL PHARMACOVIGILANCE

Offering comprehensive and integrated drug safety services for Greece, Cyprus, and Malta, our approach extends beyond the responsibilities of the LPPV/LSO. We provide marketing authorization holders with a complete local PV system, ensuring thorough coverage.

CASE PROCESSING

We are able to handle high volumes of Individual Case Study Reports (ICSRs) by ensuring both quality and compliance. To deliver optimal service, we can customize our case handling solutions to seamlessly align with your workflows and processes.

GLOBAL AND LOCAL MEDICAL LITERATURE MONITORING

Medwork offers efficient global and local medical literature monitoring services empowered by the involvement of medical doctors who are actively engaged in the review and assessment process.

CLINICAL TRIAL SAFETY

Medwork can ensure adherence to safety-related obligations for sponsors and investigators, efficiently removing this responsibility from them. This strategy enables you to concentrate solely on reaching your clinical goals. A dedicated group of experienced professionals will support you in every stage of clinical trial conduct and reporting.

MEDICAL DEVICE VIGILANCE

As a vigilance-focused organization, we have the expertise to ensure safety across substances, devices, and combinations. With materiovigilance evolving towards a pharmacovigilance approach, we're well-equipped to help medical device manufacturers navigate these new regulatory requirements using our proven, stringent principles.