Monitoring the safety of medicines, collection and analysis of adverse effects, preparation of risk management plans and periodic safety reports (PSUR, RMP, etc.), and communication with regulatory authorities.
Registration of local and imported medicinal products, including preparation of documentation and full regulatory process management.
We provide regulatory and technical support for the registration and market entry of food supplements. Our services include label and packaging compliance, preparation of usage instructions, nutritional and toxicological documentation, and full assistance throughout the regulatory evaluation process.
Preparation of technical files and expert support for the registration and conformity assessment of medical devices in accordance with applicable legislation.
To use the account, please contact us.
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...
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.
MAKROMED LLC is one of the best and leading qualified consulting companies in Azerbaijan established in 2013. Now it’s a part of the Makromedicine worldwide webportal (www.makromedicine.com).We are currently cooperating with many leading pharmaceutical companies around the world, as well as CIS countries.Through its professional team of experts with an excellent reputation in Azerbaijan pharmaceutical market, Makromed LLC offers the highest level of services available and an excellent understanding of the specifics of the pharmaceutical market and regulators.We consider each problem objectively from our largest to our most focused engagement, based on rigorous and thorough research. We follow the data relentlessly and deliver not just the conventional wisdom but also deeper and sharper insights that are actionable and give our clie
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.
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.
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.
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.
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