Pharmacovigilance

Qualitas provides well regarded Pharmacovigilance services and risk management expertise to ensure you are compliant with the legislation and therefore protecting your product assets. Our clinical knowledge and commercial understanding delivers a compliant, ethical and balanced approach to risk management. Pharmacovigilance and risk management is a passion for our experts. Pharmaceutical, biotechnology, medical device and cosmetic companies can rely on the proven expertise of Qualitas.

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For medicines, our experienced team efficiently assess and process adverse events and reactions from clinical trials and post-marketing. We operate a validated safety database and our experts will ensure you comply with the requirements for expedited and periodic reporting or, reviewing literature and safety signal detection. We provide qualified persons to be your Responsible Person, EU Qualified Person for Pharmacovigilance or Local Person for Pharmacovigilance, with the QPPV maintaining oversight for the whole PV operation.

We have significant experience in writing standard operating procedures (SOPs), safety management plans (SMPs), periodic safety update reports (PSURs) and risk management plans (RMPs) to ensure that the risk-benefit profile of your products is identified and monitored, thus safeguarding your patients safety. We are expert in safety data exchange agreements (SDEAs) and the auditing of third parties in line with a risk assessment plan, constructively improving processes and driving compliance in partner companies. We also provide PV training to ensure that employees comply with the regulatory requirements.

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In Canada, we can provide expert advice according to the Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102) and advice customers on implementation.

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We are also expert in the EudraVigilance and the Article 57 databases, registering and using them to ensure compliance with the stipulated requirements in the legislation and ensuring the related costs associated with the product entries are correct.

In addition, our experts handle incident reporting and Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN) for medical devices and for cosmetics, our team are experienced in conducting causality assessments, handling and reporting serious undesirable effects and safety assessments.

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We have also knowledge and experience in implementation of the FDA guidelines and expert knowledge of the FDA Guidance document on PV - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.

We can provide guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment, specifically on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety signal interpretation, and (3) pharmacovigilance plan development.

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If you would like information on our comprehensive Pharmacovigilance Consultancy services, don’t hesitate to get in touch with our team.