SERVICES FOR THE PHARMACEUTICAL INDUSTRY
Pharmacovigilance, Clinical Safety, Regulatory and Quality Solutions for the pharmaceutical industry
PVpharm provide services to Marketing Authorisation Holders, Sponsors of Clinical Trials and other Life science service providers.
Our objective is to help the Pharmaceutical industry to comply with Pharmacovigilance, Clinical safety, Regulatory and Quality requirements. We provide global, professional, quick, and flexible solutions to complex, specialized needs.
Our Services
Our specialities include Pharmacovigilance and Clinical Safety services, Regulatory affairs, Medical Services, EU-QPPV and Local contact person for pharmacovigilance, Pharmacovigilance and GCP Audits, EudraVigilance compliance, CTIS support, Pharmacovigilance training, including EVWeb and XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) training, Signal Detection and Signal Management using EVDAS, IDMP implementation preparation, and data management.
We provide services for drugs, devices, veterinary, food supplements and cosmetics.
We do also provide GxP support and provide GMP specialized audits.
Pharmacovigilance Services
- EU and Local QPPV Services
- ICSR Management & Medical Review
- Signal Detection and Management (including EVDAS)
- PSUR, RMP and other Safety Reports
- Pharmacovigilance System Master File (PSMF)
- Safety Database Management
- SDEA Management and Regulatory Consultancy
- Medical Literature Monitoring (global and local)
- Post-Authorization Safety Studies (PASS)
- XEVMPD and IDMP Compliance
- Quality Mangement and SOP Development
Clinical Safety
- SAE and SUSAR Management
- Medical Monitoring and Evaluation
- Development Safety Update Reports (DSUR)
- Safety Management Plan (SMP) and Investigator Brochure (IB)
- Protocol Review and Safety Input
- CTIS Portal Management
- Legal Representation in the EU / Responsible Person in EudraVigilance
- Sponsor Profile Registration in EudraVigilance
- Clinical Safety Training
- Support for Marketing Authorisation Applications (MAA)
- Quality and Compliance in Clinical Safety
Regulatory Affairs
- Regulatory strategy and planning
- Dossier preparation and submission
- Marketing Authorisation Applications (MAA)
- Gap analysis
- Life cycle management (post-authorisation)
- Regulatory database management
- Promotional and non-promotional materials
- Launch and market notifications
- Regulatory training
- Dedicated RA resources
- Scientific Advice and Agency interactions
Medical Services
- Medical Information Management
- Scientific literature search and critical evaluation
- Scientific & Medical Writing
- Preparation and maintenance of standard responses (FAQs)
- Medical review of promotional and non-promotional materials
- Systematic bibliographic searches in biomedical databases
- Critical review and summarization of scientific publications
- Management of medical inquiries from healthcare professionals and patients
- Call Centre service
- Development of medical content for educational activities
- Strategic Medical Advice
Quality
Pharmacovigilance training
Join the Pharmacovigilance Traininig VII Edition in Barcelona / Online 12-13 May 2026. Hurry up! Few seats available.
Video of the 2025 Edition
Trust in PVpharm
Testimonials
Leading Pharmacovigilance
Pharmacovigilance Classroom
PVpharm continue with the activities of the Pharmacovigilance Classroom in collaboration with the Faculty of Pharmacy of the University of Granada.
Micro-credential in pharmacovigilance
In 2025, PVpharm is honored to announce the creation of the first micro-credential in pharmacovigilance, guaranteeing comprehensive training with the endorsement of the International Graduate School of the University of Granada.
II University of Granada Pharmacovigilance Conference
The PVpharm Pharmacovigilance Classroom and the Faculty of Pharmacy of the University of Granada will organize the II University of Granada Pharmacovigilance Conference, on May 21 and 22 (Wednesday and Thursday) 2025.
These will be face-to-face sessions, which can also be followed online, aimed at professionals in the pharmaceutical industry and pharmacy offices, as well as students of the Degree in Pharmacy from the different Spanish and Latin American Universities.
News
Please contact our pharmacovigilance experts and we will be very happy to analyze your situation and discuss with you the best way to move forward.
