A pivotal year for PVpharm, which, in addition to its pharmacovigilance and clinical safety services, expands its portfolio with the incorporation of Regulatory Affairs and Medical Information
Among the most notable milestones are the sponsorship of the first edition of the Pharmacovigilance Forum, which featured the participation of the AEMPS (Spanish Agency of Medicines and Medical Devices), the creation of the first Pharmacovigilance micro-credential in Spain, and the organisation of the 2nd University Pharmacovigilance Conference in collaboration with the University of Granada.
Throughout this year, PVpharm has driven key initiatives that reinforce its role as a benchmark in pharmacovigilance, regulatory activities and scientific services.
In addition, the company has launched new strategic projects in the field of medicinal product and medical device safety, including the maintenance of a pharmacovigilance system for an active substance of significant public health relevance, the provision of comprehensive international support in Pharmacovigilance and Materiovigilance, and the full outsourcing of Pharmacovigilance and Cosmetovigilance activities.
In this context of growth, PVpharm expands its portfolio of solutions by incorporating a new specialised area in Regulatory Affairs and significantly reinforcing its Medical Information services within the Medical Services department, further consolidating its position as an end-to-end provider in regulatory affairs, medicinal product safety and scientific services. This expansion strengthens the organisational structure and consolidates a model based on highly specialised service areas.
With this evolution, PVpharm now operates a total of seven functional areas that meet the needs of health and life sciences companies throughout the entire product life cycle, from development to post-marketing:
- Pharmacovigilance Services
- Clinical Safety
- Regulatory Affairs
- Medical Services
- Audit Services
- Quality Management
- Training Services
The new Regulatory Affairs area includes essential services such as the preparation and maintenance of regulatory dossiers, variation management, strategic consultancy and support in interactions with regulatory authorities. It also integrates a dedicated Environmental Risk Assessment (ERA) block, an increasingly important requirement for innovative products. In this field, PVpharm provides expert ERA review, methodological guidance and alignment with EMA standards and those of other competent authorities.
Meanwhile, the Medical Services area significantly expands its offering through new Medical Information services. These include the management of medical enquiries, the development and updating of standard responses, systematic literature searches, critical appraisal of scientific publications, and the creation of medical content for training activities. The area also incorporates the medical review of promotional and non-promotional materials, as well as strategic support in scientific-regulatory communication.
With these seven integrated areas, a substantial strengthening of regulatory and medical capabilities, and the momentum of new strategic projects, PVpharm consolidates its position as a specialised partner capable of providing comprehensive, flexible and highly tailored solutions for health and life sciences companies in an increasingly demanding environment.