About US

KMJ pharma Ltd. specialises in regulatory affairs consulting services relating to biotech and biological products. We are ready to assist clients from Europe, the United States, Australia, Japan, China and India and other regions to achieve efficient and expedient marketing authorisation for their innovative products like medicines, dieteary supplements, cosmetics and medical devices in Poland.
We provide advice on regulatory strategy, to the compilation and submission of complete dossiers. Each of our experts has extensive experience in specialised field of biopharmaceutical science.

Needless to say, experts from KMJ pharma Ltd. has thorough knowledge and understanding of the relevant directives and guidelines that have been issued by ICH, the European and Polish authorities. It is worth mentioning at this point that our clients are provided with access to our extensive database of these regulations. However, these are but one of the foundation stones for our work. KMJ pharma Ltd. approach has always been interdisciplinary, with a strong emphasis on the science underlying the product. Accordingly, our scientists have backgrounds that are relevant and important for our consulting work, including molecular and cell biology, protein biochemistry, immunology, pharmacology and quality assurance. An advantage for the client is that our scientists require a minimum of introduction and education with respect to the subject matter of new products, since they already bring broad knowledge to the table on biotech and biological medicinal products in general.

 

Polish version