Summary
- Profile Type
- Business Offer
- POD Reference
- BOPL20250415014
- Term of Validity
- 22 April 2025 - 22 April 2026
- Company's Country
- Poland
- Type of partnership
- Outsourcing agreement
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- Polish contract research organization (CRO) with more than 10 years of experience in bioequivalence (BA/BE) and pharmacokinetic clinical trials, phase I trials and drug R&D is looking for new collaborations. Company offer include full generic and hybrid drugs development cycle: end-to-end R&D solutions, protocol writing for clinical trial, clinical part of a study in its own clinical facility, bioanalysis in its own GLP-certified lab, statistical analysis and evaluation, and final reporting.
- Full Description
-
A Polish contract research organization (CRO) specializing in early-phase clinical trials, BA/BE studies, and end-to-end R&D solutions is looking for partners within the European Union, as well as from other regions, including North America, the Middle East, and Asia.
With over a decade of experience, the company supports pharmaceutical companies from drug development to regulatory approval, covering formulation development for generic and hybrid drugs, preclinical assessments, clinical trials, and bioanalysis.
The company boasts an extensive portfolio of clinical trials and R&D projects, covering primarily neurology, cardiovascular and pain management therapeutic areas. The organization focuses on conducting bioequivalence and pharmacokinetic studies to facilitate the development and approval of generic and hybrid drugs, ensuring their compliance with international regulatory standards such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Operating state-of-the-art clinical and bioanalytical facilities, the company delivers high-precision pharmacokinetic assessments while maintaining strict regulatory compliance. Its services in clinical trials encompass protocol design, clinical study execution, bioanalysis, data management, and regulatory support—ensuring a streamlined, cost-efficient drug development process.
Through international collaborations, the company continuously expands its research capabilities, enhancing global access to high-quality, affordable medicines. - Advantages and Innovations
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The company offering a comprehensive suite of services that bridge the gap between research and commercialization. With a broad portfolio of clinical trials and R&D projects, the organization delivers tailored solutions that address the specific needs of its partners. The company employs cutting-edge bioanalytical techniques, modeling and simulation tools, and data-driven strategies to optimize study designs and enhance decision-making in drug development.
A key advantage of the organization is its fully integrated approach, combining R&D, clinical research, bioanalysis, and regulatory expertise under one roof. The clinical trial unit and bioanalytical laboratory are located within the same facility, which helps reduce study costs and minimize the risks associated with biological sample transportation. This ensures seamless study execution, reduced timelines, and enhanced data integrity. The organization adheres to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines, ensuring the highest level of quality and compliance in all research activities.
The company also offers comprehensive regulatory guidance, navigating the complex approval processes in the EU, U.S., and other global markets. This enables pharmaceutical companies to efficiently meet compliance requirements and accelerate product commercialization. - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
Partner Sought
- Expected Role of a Partner
- The company seeks pharmaceutical manufacturers and generic drug developers requiring bioequivalence (BA/BE) and pharmacokinetic studies and R&D of generic and hybrid drugs. The ideal partner should be engaged in drug formulation and regulatory submissions, looking for a reliable CRO to conduct clinical trials and bioanalytical assessments.
- Type and Size of Partner
- SME <=10
- Other
- R&D Institution
- Big company
- University
- SME 11-49
- SME 50 - 249
- Type of partnership
- Outsourcing agreement
- Commercial agreement
Dissemination
- Technology keywords
- 06001012 - Medical Research
- 06001002 - Clinical Research, Trials
- 06001001 - Biostatistics, Epidemiology
- Market keywords
- 05005022 - Other clinical medicine
- 05007007 - Other medical/health related (not elsewhere classified)
- Sector Groups Involved
- Health
- Targeted countries
- All countries