Address: Mirijevski bulevar 3
11000 Belgrade, Serbia
Phone: +381(11)3315-000
Email: office.centar@farmalogist.rs
Registration service
Product registration, preparation of documentation, pharmacovigilance, reporting
The Farmalogist team, your safe harbour
Whether related to drugs, medical devices, dietary products, cosmetics or biocides, legislation is a dynamic area that requires exceptional dedication and experience to manage successfully.
The registration service we offer to our partners is based on continuous monitoring of legislation pertaining to drugs, medical devices, dietary products, cosmetics, biocides, as well as a good knowledge of regulatory processes, numerous years of experience and good communication with regulatory institutions.
The Farmalogist team includes highly qualified professionals with extensive work experience, and a high-quality professional network, providing fast and efficient communication, and assisting with constructive advice where needed.
Our services:
Medicine
Registration/renewal of registration/notification of variation for a drug under the requirements of the regulatory bodies of the countries in which we operate include the following:
Medical Devices
We provide full service for the registration of medical devices in the Registry, amendments, additions, and extensions of medical device registrations.
Dietetic products
We provide full service for the registration of dietetic products in the database of regulatory authorities of countries of interest, renewal of registrations and amendments to the registration:
Cosmetics
We provide full service for the notifications of cosmetic products:
Important dates in the area of cosmetics production in the Republic of Serbia:
Cosmetic products placed on the market after 5 September 2019 must contain a declaration that is harmonised with the Rulebook on cosmetic products ("Official Gazette of the Republic of Serbia" No. 60/2019);
A file containing information on the cosmetic product (Product information file – or PIF) must be made before April 10, 2023, according to the Rulebook on cosmetic products ("Official Gazette of the Republic of Serbia" No. 60/2019);
Biocides
We provide full service related to the registration, amendments, additions and extensions of registration for biocidal products.
The Farmalogist team, your safe harbour
Whether related to drugs, medical devices, dietary products, cosmetics or biocides, legislation is a dynamic area that requires exceptional dedication and experience to manage successfully.
The registration service we offer to our partners is based on continuous monitoring of legislation pertaining to drugs, medical devices, dietary products, cosmetics, biocides, as well as a good knowledge of regulatory processes, numerous years of experience and good communication with regulatory institutions.
The Farmalogist team includes highly qualified professionals with extensive work experience, and a high-quality professional network, providing fast and efficient communication, and assisting with constructive advice where needed.
Our services:
Medicine
Registration/renewal of registration/notification of variation for a drug under the requirements of the regulatory bodies of the countries in which we operate include the following:
- the preparation of a registration file in accordance with local requirements and submitting the application for registration;
- the preparation of a draft text of the Summaries of Product Characteristics (SPC), the Package Leaflet (PIL) and the text for the outer and inner packaging of the drug (labelling);
- the monitoring of the registration process or registration renewal process until the obtention of a marketing permit;
- the upkeep of current registrations – the preparation, submission and monitoring of registration renewal requests, as well as variations for registered medicinal products.
Medical Devices
We provide full service for the registration of medical devices in the Registry, amendments, additions, and extensions of medical device registrations.
- Providing an expert opinion on the categorisation of a medical device by regulatory bodies);
- Reparation of the draft text of packaging and instructions;
- Coordination and submission of the necessary documentation for the purpose of registration;
- Monitoring the registration and registration renewal services
- Amendments to a registered medical device
Dietetic products
We provide full service for the registration of dietetic products in the database of regulatory authorities of countries of interest, renewal of registrations and amendments to the registration:
- Activities related to the provision of expert opinion and categorisation by reference institutions and consultations regarding drafting the declaration for the product in question
- Activities related to the provision of expert opinion on the health safety of the dietetic product by a registered laboratory
- Coordination and submission of appropriate documentation to the regulatory body within the procedure of input of a dietetic product into the database
- Registration renewal services
- Amendments to a registered dietetic product
Cosmetics
We provide full service for the notifications of cosmetic products:
- Direct consultations and preliminary analysis regarding the composition of your cosmetic product within the applicable cosmetic regulations
- Coordination of testing and analysis of cosmetic products in reliable laboratories
- Activities related to providing CPSR, part of the Product information File by experienced security assessors
- Advice and support regarding registering of products to the CPAP
Important dates in the area of cosmetics production in the Republic of Serbia:
Cosmetic products placed on the market after 5 September 2019 must contain a declaration that is harmonised with the Rulebook on cosmetic products ("Official Gazette of the Republic of Serbia" No. 60/2019);
A file containing information on the cosmetic product (Product information file – or PIF) must be made before April 10, 2023, according to the Rulebook on cosmetic products ("Official Gazette of the Republic of Serbia" No. 60/2019);
Biocides
We provide full service related to the registration, amendments, additions and extensions of registration for biocidal products.
- We provide advice with the drafting of the wording of the declaration for the product in question
- Coordination and submission of appropriate documentation to the Ministry of Environmental Protection within the procedure of registering a biocidal product in the biocidal products Registry.
- Registration renewal services
- Modifications to registered biocidal products
Marketing and promotions
Product launch services
Do you have a new product and want to show it to everyone? You have been operating in the Serbian market for a long time, but do you want to expand your business to other countries as well? Do you need a quality PLAN to launch a product based on a clearly set strategy? We have a solution for you!
This is a process encompassing market analysis, creating a sales strategy, defining the target group and competition, designing, and implementing a marketing and media plan, participation in trade fairs and meetings, field teamwork that ensures the placement of new drugs, medical devices and other pharmaceuticals on the market with more than 3800 pharmacies and medical facilities.
Sales channel management helps to develop sales and customer service programmes within a specific channel. The goal is to simplify communication between the company and the customer. To achieve it, one needs to segment channels according to the customer’s characteristics: their needs, purchasing habits, success factors, and then to adjust the programme and include goals, policies, products, sales and marketing.
This is exactly what we provide: direct daily communication with the customers on each channel.
After that goal has been efficiently met, management will have a better concept of the best marketing channel for a given customer base. The techniques used in each channel may be different, but the overall strategy must always be branded consistently during communication. The company must determine what it wants from each channel and clearly define the framework for each of those channels to produce the desired results.
Professional education, fairs, meetings
If you wish to accredit a professional lecture, a symposium, a symposium for medical doctors, pharmacists or dentists, but don’t dispose of enough information and experience, our team of associates is here to assist. We have many years of experience in the organisation of professional education seminars and meetings, ranging from smaller presentations and training to large gatherings with an international character attracting eminent domestic and international experts. With us, your professional lectures will be accredited within defined deadlines and your authority will provide a sufficient number of points for the attendee or lecturer.
Do you have a new product and want to show it to everyone? You have been operating in the Serbian market for a long time, but do you want to expand your business to other countries as well? Do you need a quality PLAN to launch a product based on a clearly set strategy? We have a solution for you!
This is a process encompassing market analysis, creating a sales strategy, defining the target group and competition, designing, and implementing a marketing and media plan, participation in trade fairs and meetings, field teamwork that ensures the placement of new drugs, medical devices and other pharmaceuticals on the market with more than 3800 pharmacies and medical facilities.
Sales channel management helps to develop sales and customer service programmes within a specific channel. The goal is to simplify communication between the company and the customer. To achieve it, one needs to segment channels according to the customer’s characteristics: their needs, purchasing habits, success factors, and then to adjust the programme and include goals, policies, products, sales and marketing.
This is exactly what we provide: direct daily communication with the customers on each channel.
After that goal has been efficiently met, management will have a better concept of the best marketing channel for a given customer base. The techniques used in each channel may be different, but the overall strategy must always be branded consistently during communication. The company must determine what it wants from each channel and clearly define the framework for each of those channels to produce the desired results.
Professional education, fairs, meetings
If you wish to accredit a professional lecture, a symposium, a symposium for medical doctors, pharmacists or dentists, but don’t dispose of enough information and experience, our team of associates is here to assist. We have many years of experience in the organisation of professional education seminars and meetings, ranging from smaller presentations and training to large gatherings with an international character attracting eminent domestic and international experts. With us, your professional lectures will be accredited within defined deadlines and your authority will provide a sufficient number of points for the attendee or lecturer.
Field force
Our dedicated and experienced teams will ensure a constant presence of your products on the market and with customers, with a growth in sales efficiency and the realisation of set goals.
Our advantage is many years of experience in sales, territorial coverage, innovative IT solutions and mobile applications that associates use daily in their work, a large base of doctors and pharmacists who enjoy a business relationship based on trust.
Hiring associates of our medical and /or commercial team is the right choice, for you optimise business costs doing so, and with maximum results of the team in the field.
Our advantage is many years of experience in sales, territorial coverage, innovative IT solutions and mobile applications that associates use daily in their work, a large base of doctors and pharmacists who enjoy a business relationship based on trust.
Hiring associates of our medical and /or commercial team is the right choice, for you optimise business costs doing so, and with maximum results of the team in the field.
