Qplus Consult
A Vigilant Partner for Pharmaceutical Companies

Pharmacovigilance systems worldwide are changing significantly due to technology advancements, increasing volumes of data available to regulators and companies, and increasing engagement of patients in healthcare decision-making. The industry has made immense progress in transitioning from reactive activities driven solely by spontaneous reports of suspected adverse reactions to more proactive monitoring based on careful planning before the product is deployedinto the market. Helping pharmaceutical organizations keep pace with these rapid changes and working for both EU Corporate organisations & local affiliates, Q plus Consult understands international as well as company-specific requirements. Even more, the company’s focus on quality and customer satisfaction has resulted in a proven record of exceeding the clients’ expectations. As experts in the field, Qplus Consult also frequently hosts in-company workshops highlighting the implementation of regulatory requirements.

Qplus Consult offers clients its vast know-how on working with complex regulatory measures from managing pharmacovigilance systems and screening literature to audits and pharmacovigilance training. The company’s adverse event management team supportspharmaceutical companies of all sizes and therapeutic groups with compliance to be applicable to PV requirements. Q plus Consult reportssuch cases to competent authorities via EudraVigilance or records it into the clients’ company-specific database. Q plus Consult’s Pharmacovigilance System Master File (PSMF) provides a detailed description of the pharmacovigilance system with respect to one or more authorised medicinal products. The organization also guides clients with the creation and shaping of their PV systems (complete or partial) and the establishment of a PSMF.

By defining KPIs and metrics, Qplus provides invaluable help to clients in the pharma industry by helping them understand gap analysis and the right implementation of GDPR for PV departments. Q plus Consult also lends a helping hand to Marketing Authorisation Holders (MAH).

When new products are ready to be launched into the market, MAH is obliged to screen medical and scientific literature to ensure that the safety information of their products and active substances is duly noted and, if required, reported to responsible authorities. The organization’s dedicated and qualified PV team is experienced in carrying out this activity on the client’s behalf and can manage all their literature-screening requirements.Additionally, the company also offers its services to perform internal audits, self-inspections, and PV reports. The audits are an essential part of any pharmacovigilance company’s quality management systems. Q plus’ experts can perform an objective analysis of a client’s PV system, examining its compliance with all European and national requirements.

With aprimary focus on building long-term relationships with each of its clients, Q plus Consult strives to provide excellent service in a timely and cost-efficient manner.To meet client expectations and keep up with market trends, Q plus has a team of enthusiastic and experienced consultantsdedicated to providing optimum service every day and have a vast collective experience spanning decades. Thanks to extensive internal and external training, Q plus Consult’s consultants remain up to date and work according to the most current legislation and regulations.

Implementing an efficient communications flow and reporting as well as regular feedback meetings with clients form the foundation of a successful collaboration with Q plus. This close relationship with its clients and the knowledge of specific life science and medtech business enables the organization to deliver tailor-made services in Europe and Switzerland.