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Your Global Partner in Regulatory Excellence

KMJ Pharma® Sp. z o.o. (LLC) is a boutique service regulatory affairs organization (RRO) providing product development services for the pharmaceutical (small and large molecules), medical device, cosmetics and food industries across Europe. Our highly experienced professionals provides specialist expertise across every aspect of a project, from early development to post-marketing.

Medicinal Products

Medical Devices

Cosmetic Products

Food Supplements

about us

The real experts in the field

Since company has been founded in Poland in 2009 we have shown steady growth. Our European roots and culture of work provide a high-quality delivery of services based on know-how, proper planning, respect, work integrity and strong focus on solutions.

Since Day 1 we continuously go against the market trends set up by global consultancy players and we do not compromise which is based on ‘quantity’ instead of ‘quality’ nor we do not mislead by sell promises and services where we do not experience.

We are trustworthy partner and a green company which takes care on a daily basis about our sustainable living environment. As an organization we have implemented ISO 9001, ISO13485 and HACCP standards and we are GDPR compliant.

about us

Our mission

Our mission is to be a niche strategic partner in Europe, guiding our clients from and outside of Europe through competence and evidence-based documentation to make optimal decisions that drive superior clinical outcomes and customers/patients satisfaction.

As a company we rely on our own network of experts as well as we are one of first members of on a high quality regulanet R+ global network, which gives our clients global capabilities ‘on demand’ from ONE source. Whenever project demands that we can act globally staying European company. Our main goal is to support companies from the pharmaceutical, medical, cosmetic and food sector, operating in Europe as well as ones from America, Africa or Asia planning to enter into European market. We provide services that include regulatory strategy (local/global) preparation documentation for new products, registration and placing them on the Polish and European market. We offer technical support to the biopharmaceutical sector and a willingness to carry out innovative projects and develop new products.

about us

Global network - regulanet®
Member since 2010

In 2010, KMJ pharma® Sp. z o.o. joined regulanet® a network of independent regulatory affairs consultancies with representation in over 90 countries throughout the world. Founded in 2001 regulanet® offers services to a wide variety of national and international healthcare and pharmaceutical clients. The members of the network provide advice and assistance on national and international projects and marketing authorisation procedures, including the decentralised, mutual recognition and centralised procedures within Europe.

Over the years the services offered by members have been expanded and now include all aspects of development, regulatory and market access in their respective countries.

about us

Gepard Biznesu award.

More than decade of success has been rewarded by the trust of our clients and awarded for a business results in 2020, 2021 and 2022 by the Business Cheetah Award.