OUR MISSION IS ALL ABOUT HEALTH...
Medicinal product – In the context of medicinal product registration services we perform the preparation and prosecution of national procedures and the entire process of maintenance throughout the life cycle of your products. It would be our pleasure to help you in the following fields of medicinal product registration:
- Support and monitoring during the application procedure for obtaining marketing authorization for a medicinal product
- Consultation and planning during the implementation procedure applications
- Creation of text packaging material, Patient Leaflet and Summary Product Characteristics of the medical product
- Respond to comments / additional requirements of relevant institutions
- Maintenance of marketing authorisation approval
- Variations of marketing authorisation for the medicinal product
- Support Programme for import of samples of medicinal products (consultation and support to import samples)
Medical devices – At your request we prepare documentation for the registration of medical devices in the register of medical devices of Bosnia and Herzegovina as well as all other necessary services needed to maintain approval, which include amendment, variation or renewal of registration.
We also inform you of any changes during the life cycle of medical devices. If you need support during the registration process of the pallet of your products, our team is here for you.
Dietary supplements – Assensus is preparing and handing documents to obtain a license for the import and marketing of dietary supplements on the territory of the Federation of BiH / RS on your behalf.
We prepare Product Information according local requirement, translate the product documentation in the local language as well as all other services required for the issue of import licenses.
From now on all you need in order to register your product can be found in one place.
In order to meet requirements in the field of vigilance, we established our PV / MV unit. We provide a wide range of services in this area that allow you as a pharmaceutical company compliance with the requirements and obligations in accordance with the legislation in force. We care about safety of your products and we perform assessment and reporting of adverse effects of medicinal product, as well as periodic submisson of PSURs and all additional services in the field of vigilance. We assess, collect and report the information about the risks of application of medical devices:
- Monitoring daily incoming communication (e.g., e-mail, telephone, and fax) for ICSRs to report to GPE.
- Handling of ICSRs and other PV data received locally in line with GPE Global SOPs and local regulatory PV requirements.
- Handling of periodic reports including PSURs, DSURs and Product safety alerts in line with GPE global SOPs and local regulatory PV Requirements.
- Tracking of reporting activities
- Managing of quarterly reporting to GPE
Major areas of Assensus services:
Assensus provides you with pharmaceutical consulting services including clinical research consulting in conducting and monitoring of clinical trials at the best local clinical institutions in Bosnia and Herzegovina:
- clinical trials including the recruitment of clinical investigators, monitoring research and providing necessary legal services
- clinical research activities based on strict adherence to the ICH-GCP Guidelines, Local Laws, EU and international regulatory requirements as well as to the medical ethics
Clinical Trials in Bosnia and Herzegovina – Why ?
- Investigators and patients are highly motivated to participate in clinical trials, as they can benefit from new drugs and have access to best physicians and better healthcare,
- Referral network developed,
- High and rapid patient recruitment,
- Number of treatment naive patients
- GCP standards incorporated into local laws
Assensus some of areas of expertise offering
Cardiology | Diabetology | Gastroenterology | Heamatology | Oncology (Breast Cancer, CRC, NSCLC, Prostate etc.) | Orthopaedics and Traumatology | Paediatrics | Pulmonology (Asthma & COPD) | Vascular and Cardio Surgery | Virology (Hepatitis C)
We can provide professional translation service in the field of health sciences.
We offer proofreading and translating technical medical texts to and from English, German and Swedish language.
Many years of experience and detailed market research of medicines, medical devices and dietery supplements in Bosnia and Herzegovina enabled us to get to know the market and offer you the best way of promoting your products.
We make presentations, negotiate meetings and visits with potential clients as well as all other promotional services.
Whether your product is new or already represented in our market we can help you find new customers as well as help you increase loyalty of existing customers, all with the aim of improving your business.
With Assensus you choose a reliable partner in the field of regulatory affairs and vigilance. Our services also include consulting services in the areas of clinical research / studies of medicinal product and medical devices in the implementation and monitoring of clinical trials / studies of medicinal product and medical devices at the best local clinical institutions in Bosnia and Herzegovina.
In addition, we can be your support during preparation of registration/renewal package in Albania/Kosovo/Montenegro/Macedonia.
The spectrum of the regulatory affairs services offered ranges from the planning and accomplishment of national application procedures, procedures of first registration, renewal and variation for medicinal products, medical devices, dietary supplements and cosmetics.
In the field of pharamacovigilance on request of our clients we perform assessment and reporting of adverse effects of medicinal product, as well as periodic submission of PSURs and all additional services in the field of vigilance.
All activities are carried out by an experienced and well educated team of experts which would be pleased to support you.
A wide spectrum of our services enables a pharmaceutical company compliance with the requirements and obligations in accordance with national legislation.
Muhameda Kantardžića 3, Sarajevo 71000, Bosnia and Herzegovina
+387 33 217 096
+387 61 191 998
Monday-Friday: 08:00 – 17:30