Make sure all of
your products
fall in line even
with the strictest
regulations.

Safety monitoring is one of the most important steps in your product’s lifecycle. We have the medical expertise and continually educated safety specialists that add value to your organization while ensuring quality service and saving you valuable time.

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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

Pharmacovigilance helps you minimize potential risks that could harm your patients. This is why it is crucial to appoint someone you can trust completely with your products.

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

We have developed a system for performing pharmacovigilance activities at the local and global level. Our system also includes an organizational structure that allows the implementation of all these activities.

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

Each marketing authorization holder (MAH) is responsible for establishing a pharmacovigilance system, providing its detailed description and having a constantly available EU or local Qualified Person Responsible for Pharmacovigilance (QPPV).

The MAH can appoint a Responsible Person instead of a QPPV by contractual agreement to manage all pharmacovigilance activities according to regulatory requirements.

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

About Pharmacovigilance
Monitoring Medicinal Products

Literature screening

It is important to keep track of literature regarding the safety and efficacy of your product.

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.

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

If a client requires a literature search relating to a specific matter, we can offer an optimal solution in line with specific requirements thanks to our technical resources and know-how. We can also conduct a search of specific areas, and write up a report with all the necessary information.

Post-authorization safety study (PASS)

Even after the authorization of your product, our job is not over. There is always room to build on your product’s safety and quality.

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?

A study is classified as PASS when the main aim for initiating the study is to:

  • 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

PASS can either be clinical trials or non-interventional studies. We offer services of non-interventional studies, whereby PASS protocols, updated study protocols following substantial amendments and final study reports should be submitted to the competent authority where the study is being conducted.

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.

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If you want to ensure the safety and
quality of your product, we invite you to

If you want to ensure the safety and
quality 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 2420 872
Pharmacovigilance: +385 1 5588 297
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

12 + 6 =

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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)