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.
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 LLC 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
Parmacovigilance
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.
No, this case is considered as an initial registration. In accordance with the relevant legislation, resubmission for registration should be applied to the relevant authority at least 210 (two hundred and ten) calendar days before the expiration of the validity period of the state registration.
Pharmacovigilance in the postmarketing phase supports drug development by identifying safety issues and guiding corrections in use.
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 is crucial for monitoring the safety of drugs and medical products in the market, detecting and eliminating side effects, and minimizing risks for patients.
“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.”
Call us: Mob: +994777276006
Call us: Tel/Fax: +994125683003
E-mail: [email protected]
Address: Binagadi district ,Svetlana Mammadova 203C Baku , Azerbaijan AZ1114
Call us: Mob: +994777276006
Call us: Tel/Fax: +994125683003
E-mail: [email protected]
Address: Binagadi district ,Svetlana Mammadova 203C Baku , Azerbaijan AZ1114
"VITAPHARM-COM" LLC recommends "Makromed" LLC as a professional business consultant. An analysis of the pharmaceutical market in Azerbaijan was conducted for our products, and their registration was successfully completed. The pro...
"Jurabek Laboratories" LLC recommends "Makromed" LLC as professionals in their field and individuals who know their business well. Our company, collaborating with "Makromed" LLC since 2020, has had only a positive experi...
With this letter, Vida Verde Pharm LLC informs that during its cooperation with Makromed LLC it has managed to establish itself as a reliable and professional partner. The main distinguishing feature of the work is the high organization and efficienc...
We have been benefiting from the medical consulting services of MAKROMED MMC for many years now. It is a pharmaceutical consulting company represented by highly productive, attentive, and experienced staff. I would say that the expression "maste...
