Regulatory
Affairs

Thanks to the constant monitoring of legal regulations, standing up for the client and meticulous work, the team of the NIC Pharmaceutical company is able to offer clients a high-quality and efficient service of performing all tasks of the regulatory process. Our partners and clients are satisfied with good communication we have with the relevant institutions and working dynamics we maintain, as well. The expert team of NIC Pharmaceutical is a reliable partner in all complex regulatory procedures.

 
Subtract-down-red–big

Regulatory
Affairs

Thanks to the constant monitoring of legal regulations, standing up for the client and meticulous work, the team of the NIC Pharmaceutical company is able to offer clients a high-quality and efficient service of performing all tasks of the regulatory process. Our partners and clients are satisfied with good communication we have with the relevant institutions and working dynamics we maintain, as well. The expert team of NIC Pharmaceutical is a reliable partner in all complex regulatory procedures.

 
Subtract-down-red–big

Registration of Medicines and Medical Devices

NIC Pharmaceutical performs service registration and renewal of registration for medicines and medical devices for its clients in accordance with the requirements of the Medicines and Medical Devices Agency of Serbia (ALIMS). Our consulting team guides the client through all stages of the procedure. We know what the license applicant must have and what are the necessary steps in order to obtain or renew the license holder's right for a drug or medical device.

In the process of issuing or renewing a license, the Agency may also request some other data important for the process. We help in the interpretation and implementation of those obligations.

For more information about the service of registration of medicines and medical devices, look at the website registracijalekova.rs.

Registration of Medicines and Medical Devices

NIC Pharmaceutical performs service registration and renewal of registration for medicines and medical devices for its clients in accordance with the requirements of the Medicines and Medical Devices Agency of Serbia (ALIMS). Our consulting team guides the client through all stages of the procedure. We know what the license applicant must have and what are the necessary steps in order to obtain or renew the license holder's right for a drug or medical device.

In the process of issuing or renewing a license, the Agency may also request some other data important for the process. We help in the interpretation and implementation of those obligations.

For more information about the service of registration of medicines and medical devices, look at the website registracijalekova.rs.

Preparation of Documentation for the Opening of Wholesales

We do consulting in relation to space, equipment, means of transport, personnel, conditions for storing and keeping medicines and medical devices. Furthermore, we consult our clients about conditions that must be met by legal entities which carry out the wholesale trade of drugs and medical devices.

In accordance with the Rulebook, we consult and prepare documentation for the opening of wholesales of medicines and medical devices.

We create written standard operating procedures for quality system assurance, a document that every wholesaler must have.

We are preparing the Organizational Scheme, the plan for the immediate withdrawal of medicines and medical devices from circulation and the Request for obtaining a permit for the wholesale circulation of medicines and medical devices.

Registration of Dietary Supplements

The list of our services includes service registration of dietary supplements. We consult clients and prepare the necessary documentation in accordance with the requirements of the competent regulatory body, the Ministry of Health of the Republic of Serbia.

We provide consulting and expert opinion regarding the registration of a dietary product in the database of the Ministry of Health.

We prepare the declaration of the dietary product as well as the Request for the entry of the dietary product into the database of the Ministry of Health.

Entrust us with the regulatory affairs, be in safe hands!
Back to Top
Subtract-up-black
ENG