We help life science companies meet their pharmacovigilance obligations by establishing and maintaining state of the art pharmacovigilance systems. Our highly experienced and trained PV professionals can support you with any individual PV activity as well as implement our comprehensive PV system as a full solution.
Provision of Local Safety Officers / Local Persons for Pharmacovigilance (LPPV/LQPPV)
Named Deputy LPPV and 24/7 availability
Weekly local medical and scientific literature screening
Support in creation and maintenance of local PV systems (local SOPs, etc.)
Local PV regulatory intelligence and consultations on applicable laws and legislation changes relating to PV
Collection and processing of safety information on country-level from any source (literature, local safety mailbox, phone enquiries, etc.)
Medical Information inquiries handling in local languages, including 24/7 customer-specific hotline
PV training of local affiliates (e.g. sales teams, etc.)
Local support with implementation of Risk Minimisation Measures (Educational Materials, DHPC communications, etc.)
Handling of National Competent Authority requests and inspections
Local Pharmacovigilance Services
Our experienced team of Local Safety Officers (LSO) / Local Persons for Pharmacovigilance (LPPV) represent MAHs on country-level in Lithuania, Latvia, Estonia, Finland, Sweden, Norway, Denmark, Iceland.
Set-up and maintenance of Pharmacovigilance System and Pharmacovigilance System Master File (PSMF)
EU/EEA Qualified Person responsible for Pharmacovigilance (EU-QPPV) and Deputy QPPV
EudraVigilance registration and maintenance, including medicinal product data reporting to XEVMPD
Processing and reporting of Individual Case Safety Reports (ICSRs)
E2B and CFR21 compliant Safety Database
Global and local literature monitoring
Signal detection and management
Development and submission of Risk Management Plans (RMPs), as well as implementation of risk minimization measures (DHPC, educational materials)
Development and submission of Periodic Safety Update Reports (PSURs)
Pharmacovigilance audits and inspections handling
EU/EEA Pharmacovigilance System
Regulatory Affairs Services
Our comprehensive regulatory affairs services are dedicated to help our customers achieve maximum compliance and timely approvals in marketing their pharmaceuticals, medical devices, cosmetics and food/dietary supplements. We specialize in country-level regulatory support and can assist you from initial marketing authorization applications through to complete product life cycle maintenance:
Dossier gap-analysis, documentation compliance review
Marketing authorization applications (National Procedure and DCP/MRP applications)
Obtaining a DCP slot with one of the Baltic countries as the RMS
Acting as the Marketing Authorization Holder
Marketing authorization maintenance (renewals, variations, Rx/OTC switch, MA transfer)
Management of product information (translations, editing, proofreading, etc.)
Management and approval of artworks and promotional materials
Local regulatory intelligence (regular updates on national regulatory legislation changes)
Notifications for Medical Devices and Food Supplements
Reimbursement Services
Our expert knowledge on the Baltic national reimbursement systems, mechanisms and processes, will help you navigate a route to access – from initial market access consultancy all the way up to obtaining reimbursement for medicinal products and medical devices. We can help you with:
Strategy and consulting on national requirements
Pharmacoeconomic analysis (cost minimization, cost effectiveness, cost utility)
Budget impact analysis
Localising global health economic models
Therapeutic value proposition
Preparation of application dossiers in line with local requirements
Submissions of applications and communication with national authorities (follow-up, preparation of answers to queries, liaison between the client and local authorities, etc.)
Price negotiations with national authorities
Market Access Services
We can help you understand the market potential of your current and potential future products in the Baltics, assess reimbursement landscape, evaluate market access opportunities and identify any identifying challenges or risks. Our market access support services include:
Local epidemiology data gathering
Intelligence on local treatment guidelines
KOL engagement
Payer interaction
Reimbursement pathways
Reimbursement and price negotiation support
Early access programs (EAP, CUP, NPP)
Clinical Trial Set-Up and Management
We provide comprehensive support in setting up and managing international clinical trials and medical device investigations in the Baltics – from initial study feasibility and clinical trial applications, through to routine monitoring and site management, up to query resolution and site closure. We work in full compliance with GCP guidelines, applicable international and local regulations, ethical standards, and can support you with all country-level clinical research activities in Lithuania, Latvia and Estonia:
Study feasibility, site identification and selection
Collection of necessary documents from sites
Clinical Trial Application review, preparation and adjustment
Regulatory submissions to Ethics Committees and Regulatory Authorities
Local project management
Site Initiation Visits
Site Monitoring Visits (clinical trial monitoring)
Site Close-Out Visits
Site Activation Visits and Quality Check Visits
On-site training
Site interaction and support
Site file maintenance
Query management
Drug accountability, IMP and other material coordination
Site Management & Support Services
Let the investigators focus on treating the patients, we will handle the rest. Our experienced Site Coordinators can remove the administrative clinical trial burden from the investigators allowing them to concentrate on enrolling and treating patients. Depending on Sponsor’s and Investigator’s requirements we can work both on-site and remotely, assisting with:
Patient recruitment & retention activities
Coordination of patient visit schedule (tracking, scheduling, reminding, etc.)
Management of clinical trial materials, lab-kits and study medications
Management of couriers and shipments (lab samples, dry-ice, etc.)
CRF data entry and query resolution
Investigator Site File management
Maintaining communication with all parties on behalf of the site
Preparation for and assistance during monitoring visits and site audits/inspections