Get in control
of patient safety.
your products
fall in line even
with the strictest
regulations.
Ensure regulatory compliance and outsource to a QPPV as you expand into the EU and global markets. The safety of your medicinal products is of the utmost importance to us. With our pharmacovigilance service, you will never need to worry that any risk or ADR might go unnoticed.
Our staff
Our Pharmacovigilance Department consists of highly educated, professional and compliant staff with the necessary organizational and technical support to meet the individual needs of our clients, all in compliance with the legislation of the relevant country.
Our system
It is possible to separately contract comprehensive services and/or individual and temporary jobs in the field of pharmacovigilance for individual contractors.
Appointing a Responsible Person
The MAH can appoint a Responsible Person instead of a QPPV by contractual agreement to manage all pharmacovigilance activities according to regulatory requirements.
Achieve compliance through weekly screenings
Our service includes:
- EU QPPV
- Local QPPV
- 24/7 availability + DQPPV
- Full-service package or special
- service package
- Literature screening
- Fully validated safety database
- Establishing and managing the pharmacovigilance system
- Pharmacovigilance System
- Master File (PSMF) preparation and maintenance
- Medical writing (PSUR, RMP, PBRER, PADER, DSUR, SAR, Addendum to the Clinical Overview etc.)
- Overview of the safety profile and all safety issues of medicinal products
- Acting in accordance with the established system of pharmacovigilance and implementing changes to the system if required
- Pharmacovigilance inspection contact
- Electronic reporting of adverse reactions (E2B)
- Monitoring of adverse events: collection, processing, quality check, coding, classification, medical assessment and electronic reporting of individual cases of adverse events within the statutory period (Individual)
- Case Safety Report (ICSR)), follow up, detecting duplicates)
- Continuous monitoring of the safety profile of medicinal products (signal detection, assessment of risk-benefit ratio, notifying regulatory authorities of the medicinal product’s safety profile)
- Development of frequently asked questions (FAQ) database for company responses to medical inquiries
- Direct Healthcare Professional Communication (DHPC)
- Risk Minimization Measures (RMM) Reporting of appropriate safety information to regulatory authorities and ethics committees
Monitoring Medicinal Products
Literature screening
We provide literature screening services as part of the pharmacovigilance system and/or on the client’s request ( such as retrospective literature screening or screening as part of our medical writing service etc.).
Through correct literature screening procedures, you sustain the quality and safety of your medicinal products.
Achieve compliance through weekly screenings
Medical and scientific journals are screened for data relating to:
- Individual Case Safety Reports (ICSRs) including requested and nonrequested reports
- Published studies containing new safety findings
- Publications from congresses or abstracts from meetings
- Publications from registries, studies or Drug Information Centers, only if the author associates a specific adverse event with one of the products or with a product with the same International Non-proprietary Name (INN)
Literature screening for other purposes
Post-authorization safety study (PASS)
A post-authorization safety study (PASS) is a study carried out after a medicinal product has been authorized to obtain further information about its safety or to measure the effectiveness of risk management measures.
What classifies as a PASS?
- Quantify potential or identified risks
- Evaluate the risks of a medicinal product used by a patient population for which safety information is limited or missing
- Evaluate the risks of a medicinal product after long-term use
- Provide evidence about the absence of risks
- Assess patterns of drug utilization that add knowledge regarding the safety of the medicinal product or the effectiveness of an RMP
- Measure the effectiveness of an RMP
Our PASS services
Our service includes:
- Communication with MAH and participation in communication with the Regulatory Authority
- Assign an investigator for the PASS
- Review of study protocols
- PASS monitoring
In addition, we also offer services of Vigilance, Cosmetovigilance and Pharmacovigilance in Clinical Trials.
If you want to ensure the safety
of your product, we invite you to
If you want to ensure the safety
of your product, we invite you to
Contact us
Headquarters
Lašćinska cesta 40
HR-10000 Zagreb
Croatia
Office
Planinska ulica 13/2
HR-10000 Zagreb
Croatia
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com
Pharmacovigilance
farmakovigilancija@martifarm.com
Tel: +385 1 5588 297
Legal info
Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121
OIB
Share capital
Authorized representative
29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
Bank account
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)
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