We provide comprehensive pharmacovigilance services, including continuous safety monitoring of medicinal products, collection and assessment of adverse event reports, preparation of PSUR, RMP, PSMF and other pharmacovigilance documentation, as well as regulatory communication support.
Professional support for the registration and marketing authorization of locally manufactured and imported medicinal products in the Republic of Azerbaijan, including dossier preparation, regulatory submission, expert review follow-up and communication with competent authorities.
We provide professional support for the registration of food supplements in the Republic of Azerbaijan, including preparation of required documentation, review of composition, labeling, packaging and directions for use in accordance with applicable regulatory requirements.
We provide professional support for the registration of medical devices, including preparation of required documentation, review of technical and conformity materials, expert assessment follow-up and compliance with applicable regulatory requirements.
Development of design solutions for pharmacies, clinics, medical centers, warehouses and other healthcare facilities in accordance with licensing, sanitary and regulatory requirements, including preparation of technical documentation and professional project support.
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All types of pharmaceutical services are carried out
As Makromed company, we approach each customer individually
We are ready to explain initial information to you free of charge
MAKROMED LLC provides professional consulting services on registration, re-registration and registration of changes in registration requirement documents of medicines in the...
In accordance with the legislation of the Republic of Azerbaijan, the sale of Food Supplements (FS) in the territory of the country is allowed only after their state registration....
MAKROMED LLCÂ also offers the following services. Pharmaceutical market research: Makromed LLC analyzes the Azerbaijani pharmaceutical market based on reliable statistical...
Projecting is a crucial stage for an establishment to acquire a license and ensure effective operations. Designing medical and pharmaceutical facilities is a complex and...
Medical Device Registration in Azerbaijan Makromed MMC provides professional regulatory services for manufacturers, distributors, importers and local representatives seeking...
Here you can report adverse effects arising from the use of medicines and vaccines. Then, select the appropriate option to proceed to the next page. Please fill in the information as completely as possible.
About Us MAKROMED LLC is a professional consulting company established in Azerbaijan in 2013, specializing in pharmaceutical, medical and regulatory consulting. We provide comprehensive support to local and international clients in the registration and re-registration of medicines, medical devices, food supplements and cosmetic products, as well as pharmacovigilance, GMP/GDP/GxP compliance, licensing, medical facility planning, market access and post-market processes. Makromed’s service model covers the key stages of a product or project lifecycle — from initial assessment and regulatory strategy to documentation, expert review support, professional communication with relevant authorities and result-oriented implementation. Our objective is not only to prepare documents, but to bring regulatory accuracy, practical expertise and lo
Yes, any information regarding the quality, effectiveness, and safety of the medicinal product should be reflected in the instructions for the use of the medicinal product for consumers.
Pharmacovigilance in the postmarketing phase supports drug development by identifying safety issues and guiding corrections in use.
In the territory of the Republic of Azerbaijan, the license holder must appoint a person responsible for pharmacovigilance with the qualifications outlined in subsection 2.1.5 of the Regulation. The license holder is required to inform the Agency of the name and contact information of the person responsible for pharmacovigilance.​​​​​​​
According to the legislation of the Republic of Azerbaijan, the state registration expertise of the medicinal product consists of two stages: initial and specialized expertise.
Yes, it is. In accordance with the "Rule of Conducting the Expertise of Medicines" approved by the Resolution of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, No. 502, each medicine manufactured outside the country must be submitted to the relevant authority, and a registration certificate document allowing its import into the country must be provided.
“Optimum nutrition is the medicine of tomorrow.”
"Developments in medicine and agriculture have saved more lives throughout history than have been lo...
User "Everything is poisonous. The key is in its dose."
“The greatest medicine of all is teaching people how not to need it.”
“Medicine is not only a science; it is also an art. It does not consist of compounding pills and p...
Wherever the art of Medicine is loved, there is also a love of Humanity.”
“Laughter is the most inexpensive and most effective wonder drug. Laughter is a universal medicine...
"The greatest medicine of all is teaching people how not to need it.”