mediReg Doradztwo Farmaceutyczne

We are pleased to introduce mediReg – your partner in achieving success in the pharmaceutical industry!

mediReg is a dynamic company specializing in pharmaceutical and regulatory consultancy. Our mission is to support companies operating in the pharmaceutical, medical, cosmetic, and dietary supplement sectors in the process of bringing their products to market. With extensive experience gained at the Office for Registration, the European Medicines Agency (EMA), and within the pharmaceutical industry, we provide comprehensive and reliable support at every stage of the registration process.

What sets us apart?

Expert knowledge in regulatory affairs, backed by practical experience in preparing documentation, managing registration processes, and interpreting legal requirements.

In-depth understanding of the production process and the challenges of launching new products, thanks to our collaboration with pharmaceutical manufacturers.

A comprehensive range of services, including the registration of medicinal products, medical devices, dietary supplements, and cosmetics, as well as monitoring adverse events, providing specialist translations, and offering full post-registration support.

Specialization in the registration of clinical trials in the CTIS (Clinical Trials Information System), including preparation of documentation compliant with Regulation 536/2014, submission, and monitoring of the registration process.

Management of adverse event reporting from clinical trials, ensuring compliance with applicable standards and safeguarding participant safety.

mediReg services include:

Registration of medicinal products in Poland and through European procedures (MRP/DCP).

Lifecycle management of products (post-registration changes, re-registrations).

Management of parallel import and distribution.

Preparation of GMP/GDP documentation for manufacturers and pharmaceutical wholesalers.

Classification and registration of medical devices, dietary supplements, and cosmetics.

Conducting readability testing of patient leaflets in accordance with EU requirements.

Professional medical translations.

Registration of clinical trials in the CTIS system and management of pharmacovigilance in clinical trials.

Why choose mediReg?

At mediReg, we combine advanced knowledge, experience, and dedication to help our clients achieve their business goals. We treat each client individually, tailoring our services to meet their needs. We prioritize the highest quality, reliability, and full compliance with current legal regulations.

If you’re looking for a partner to help you successfully launch your products, register clinical trials in the CTIS system, and manage all aspects of registration, monitoring, and safety, we invite you to collaborate with us!

Country: Poland
Voivodeship: mazowieckie
Postal Code: 03-130
City: Warsaw
Street: Kamińskiego 18/32
phone: 48 790 500 725
e-mail: medireg@medireg.pl
www: medireg.pl
industry: EN - Pharmaceutical Industry