Services we
provide
About us

Pharmacovigilance

Pharmacovigilance
activities

Materiovigilance Services

Marketing authorization
and notification
of medical devices

Sollertis is a start-up company designed to providing strategic and operational support for partial or full outsourcing of vigilance responsibilities. Sollertis provides a comprehensive, high-quality set of pharmacovigilance services that are fully compliant with regulations.

Our aim is to assist our clients in adhering to strict regulatory standards and managing the risk-benefit profile of their products, in order to maximize product potential, while prioritizing patient safety.

World Map

Our clients
around the world

  • Germany
  • France
  • Russia
  • Switzerland
  • Italy
  • Poland
  • USA
  • Lithuania
  • Czech Republic
  • Canada
  • Argentina
  • Moldova

Pharmacovigilance serveses

Sollertis Pharmacovigilance services in Moldova is a
Comprehensive Drug Safety Solution for
your company’s products.

  • Local Contact for Pharmacovigilance
    Providing LCPPV/LSO and deputies to meet regulatory requirements.
  • Local PV System Management
    Managing the local pharmacovigilance system for Marketing Authorization Holders.
  • 24/7 Availability
    Ensuring continuous availability for pharmacovigilance-related matters.
  • Document Submission
    Submitting relevant pharmacovigilance documents to Local Competent Authorities.
  • Handling Safety Requests
    Managing safety requests and translating them from the local language to English.
  • Communication with Authorities
    Providing expert support and communication with local regulatory authorities.
  • Support During Inspections
    Supporting regulatory inspections and ensuring compliance readiness.
Local Support

Local support

Pharmacovigilance

ICSR Case

ICSR Case

Management

  • ICSR Management
    Handling Individual Case Safety Reports (ICSRs) for both domestic and international cases with timely reporting to local authorities.
  • Handling MAH Requests
    Implementing Marketing Authorization Holder’s requests for safety information from national authority databases.
  • Reconciliation Process
    Ensuring the reconciliation process for safety information is conducted accurately.
  • Safety Mailbox Management
    Managing the safety mailbox for efficient handling of safety-related communications.
  • Local Literature Review
    Recommending and reviewing local journals and websites for pharmacovigilance purposes.
  • Adverse Event Management
    Identifying, assessing, and processing adverse event reports related to company products.
Local Literature

Local Literature

Review

RMPs and PSURs

RMPs and PSURs

Risk Management

  • RMP and PSUR Support
    Providing local support in handling Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs).
  • Timely Submission
    Ensuring timely submission of PSUR (PBRER) and RMP to Local Competent Authorities as per the schedule.
  • eRMM Implementation
    Managing local implementation of additional Risk Minimization Measures (eRMMs), including Educational Materials and DHPC communications.
  • Regulatory Monitoring
    Regulatory tracking and analysing pharmacovigilance regulations and legislative changes to ensure compliance.
Regulatory Monitoring

Regulatory monitoring

Local PV, intelligence/legislation

Materiovigilance services

At Sollertis, we are actively developing comprehensive vigilance
services to monitor and manage the safety of medical devices
throughout their lifecycle.

Materiovigilance Background
  • MDV System Management
    Setting up and maintaining a complete Medical Device Vigilance (MDV)
    system for all device types.
  • Adverse Event Handling
    Collecting, investigating, and assessing Adverse Device Effects (ADE)
    and Medical Device Incidents (MDI).
  • Regulatory Reporting
    Submitting ADEs and MDIs to Local Competent Authorities.
  • Compliance Reporting
    Providing monthly compliance and status reports.
  • ADE and MDI Reconciliation
    Ensuring reconciliation of ADE and MDI data.
  • Periodic Summary Reporting
    Submitting Periodic Summary Reports to Local Competent Authorities.
Contact background

Contacts

We will be happy to talk to you on
any of your questions.

Do not hesitate!

Call us

+373 69 1464 50
Call

24/7 availability.

E-mail us

ndyulger@gmail.com
Contact

We usually answer in
1 business day.