Pharmacovigilance

We help you set up a modern PV system that ensures an optimal benefit–risk profile throughout all stages of a product’s development. With our many years of experience, we create a connected system within your organization that fosters transparency, enables tailored solutions and delivers efficiency, turning pharmacovigilance into a strategic success factor for your company.

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Our services in detail:

Development & Management of the PV system

A strong pharmacovigilance system starts with a clear structure. We support you in setting up, maintaining and continuously developing your PV system.

Our services include:

• Establishment & optimization of the PV system
• Acting as Qualified Person Responsible for Pharmacovigilance (QPPV) in accordance with Article 23 of Regulation (EC) No. 726/2004
• Preparation & maintenance of the Pharmacovigilance System Master File (PSMF)
• Development & implementation of Standard Operating Procedures (SOPs)
• Preparation & updating of the Risk Management Plan (RMP)
• Conducting internal & external audits
• Support during regulatory inspections
• Support in the planning of PASS/ NIS
• PV training programs

Strategic Analysis & Risk Management

Pharmacovigilance is not only reactive, it requires foresight. We support you in all aspects of signal detection, signal management and risk management.

Our services include:

• Signal detection from non-clinical & clinical data
• Signal prioritization, validation & assessment
• Conducting benefit–risk evaluations
• Preparation of DSURs, PSURs & PBRERs
• Implementation of risk-minimization measures & evaluation of their effectiveness
• Maintenance of CCDS/ RSI & implementation into SmPC/ PIL
• Support in risk communication

Local Expertise & Regulatory Network

Effective pharmacovigilance relies on local expertise. We ensure compliance with country-specific requirements and facilitate smooth communication with local authorities.

Our services include:

• Assumption of the role of the German Local Safety Officer (Stufenplanbeauftragte, SPB) in accordance with § 63a (1) of the German Medicines Act (AMG).
• Establishment & management of local PV structures & contact points
• Communication with national authorities, ethics committees and partner companies
• Training and coaching of local PV teams

Operational Excellence in Safety Management

In operational PV, we ensure that safety-relevant information on your medicinal products is collected, processed and made available for further evaluation.

Our services include:

• Individual Case Safety Report (ICSR)/ case processing
• Literature search & monitoring
• Database management & maintenance (SPOR, xEVMPD/ Article 57)