Archives: Członek

MSCOMM Events & Marketing Agency creates unique event and marketing projects for Polish and international companies and institutions. It specialises in organising various events – from congresses through meetings to galas, including unique brand zones and other unconventional projects. It has many years of experience and a creative and professional team of specialists who approach each client and brand individually.

About SHIMI – Your trusted IT partner

SHIMI enables the digital transformation of companies through the delivery of bespoke IT solutions and outsourced teams.

Operating globally, our experts have successfully delivered solutions to clients in highly regulated sectors with demanding security requirements.

Our specialists can support you in a wide range of projects–from infrastructure and hardware.

WKB Lawyers is one of the largest Polish law firms, serving as a trusted partner for both domestic and international clients. What sets us apart is our ability to combine in-depth
legal expertise with a visionary business approach. With a team of over 140 professionals specializing in nearly 40 areas of business law, we craft tailored legal strategies built on a unique blend of knowledge, experience, and insight into diverse economic sectors. At WKB, we don’t just advise – we help our clients uncover new opportunities and build a competitive edge.

Condair is the leading manufacturer and provider of complete solutions in the areas of humidification and evaporative cooling, with a comprehensive portfolio including products, services, experience and know-how. Today, with approximately 740 employees, we operate production sites in Europe, North America and China, are
represented in over 70 countries in the world. Condair Group has its own sales organization on the Polish market – Condair Polska Sp. z o.o. with 4 sales branches in Poland and its own service department.

MONTANA SA is a Polish company with nearly 100 years of tradition, specializing in steel structures and equipment for heavy industry, energy, and railways. We provide cutting,
bending, welding, and steel processing for elements up to 5 tons, as well as medium-voltage energy project execution. Certified to ISO standards, we operate a 15,000 m² production facility.

JTI is a dynamic organization of over 46,000 employees, headquartered in Geneva, Switzerland. We are a leading international tobacco and vaping company, a subsidiary of JT Inc. which began operations 25 years ago when Japan Tobacco acquired the non-US operations of RJR Nabisco Inc. Since then, we have achieved over two decades of growth. We own some of the world’s best-known brands, including Winston and Camel, respectively the second and third largest global tobacco brands. Other major international brands are MEVIUS and LD. Our portfolio brings together the rich heritage of traditional tobacco as well as the latest technical and scientific innovation in Reduced-Risk Products (RRP). In 2024, we were recognized as a Global Top Employer for the 10th consecutive year by the Top Employers Institute, with certifications in 47 countries, across five regions.

Biokinetica S.A. is a Clinical Pharmacology Unit specializing in Early Phase studies, including First in Human, Biosimilars, and Clinical Pharmacology trials in healthy volunteers and patients. Globally recognized for cost- and time-efficient solutions, and excellent recruitment rates. The FDA-inspected unit partners with leading CROs, pharma, and biotech companies, and is affiliated with a cardiology hospital.

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!

CQUE transforms bold ideas into market-ready solutions with our comprehensive digital services, including Strategic Sourcing (IT Recruitment and a dedicated FlexTeam of specialists), Digital Strategy & Design Development, Software Engineering, and AI-powered Solutions. We take your ideas from the whiteboard to the market, delivering measurable and business-ready results.

RINCO is among the world’s leading companies in ultrasonic technology for industrial applications. We develop and manufacture ultrasonic welding machines and cutting devices for the efficient processing of plastic parts, textiles, and food products.

With over 130 employees and representatives in more than 40 countries, we provide expert advice and comprehensive support to our customers worldwide.