Safety doesn’t happen by chance. It happens by vigilance.
A solid extension of your pharma or biotech safety team for both full a PV system and a local safety network across Europe and emerging markets (CIS & EAEU).
They anticipate your business growth and offer both local expertise as well as up-to-date knowledge of global regulations. The team is fit to handle large Post-Authorization projects and well-suited to tend to small and medium biopharma in clinical development. We often integrate our Pharmacovigilance services with our Medical Information and Regulatory Affairs services, working efficiently as a multi-disciplinary team.
|Biomapas team experts are able to provide clinical safety service in a wide range of therapeutic areas and product classes, starting from clinical safety set-up, going to continuous surveillance of the study and finalizing with study closure activities. Our experienced team offers fast and reliable safety management plan development and smooth execution. We ensure efficient safety database set-up, including individual tenant environment set-up, specific case attributes and data migration.||Clinical Safety |
PV System & QPPV
|Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System, and offers experienced EU Qualified Person for Pharmacovigilance to take responisiblity of your pharmacovigilance affairs. |
|Pharmacovigilance System set-up & QPPV|
|We offer all necessary global, comprehensive drug safety services to complete or entirely outsource your pharmacovigilance activities. Our expert team members, who hold degrees in medicine and pharmacy, maintain consistent case processing according to all EMA requirements while recording cases in Safety Database with supreme at least four-eye quality check and assessment. |
|Local Pharmacovigilance Operations |
PV System & QPPV
QPPV & LPPV Network
Inhouse experienced EU QPPVs and a network throughout Europe to comply with local requirements.
Not another middleman, working through own workforce across Europe and CIS
We combine our Medical Information expertise with RA & PV in multi-disciplinary teams.
MAH is the Key to the Pharmacovigilance
Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers (HCP), pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder (MAH).
A Global Player That Understands Local Nuances In Hard-To-Reach Regions