Badania biorównoważności
Od planowania po raport końcowy
Badania kliniczne
Fazy I–IV
Doradztwo regulacyjne
Strategia, dokumentacja, kontakt z urzędami
Analityka i bioanaliza
Precyzyjna ocena danych
Zarządzanie projektami
Kompleksowa koordynacja badań
Who are we?
Global Pharma supports pharmaceutical companies in conducting bioequivalence and clinical studies. We act as a project partner, ensuring compliance with the requirements of the EMA, FDA, and local regulatory agencies.
Our core competencies
01
Study design and preparation
- Development of a comprehensive study protocol in accordance with the highest regulatory standards.
- Optimization of the study design in terms of efficiency and cost.
- Preparation of the complete documentation required to submit the study (including CTA/IND).
- Fast and effective communication with regulatory authorities and bioethics committees.
- Compliance with Good Laboratory Practice (GLP) principles in preclinical studies.
02
Study execution
- Recruitment and management of study participants using modern recruitment methods.
- Strict control over drug administration and monitoring of pharmacokinetic and pharmacodynamic parameters.
- Full handling of eCRF and systems compliant with 21 CFR Part 11 and GDPR.
- Integrated data management and statistical analysis ensuring precise results.
- Compliance with Good Clinical Practice (GCP) principles at every stage of the study.
Why work with us?
- A team experienced in European and international studies
- Compliance with GCP, ICH, and local guidelines
- Efficient communication and project flexibility
- Timeliness and transparency of reporting
Who do we work with?
We work with pharmaceutical and biotechnology companies, research centers, and scientific institutions in Poland and abroad.
Our core competencies
Study design and preparation
Study execution
Results reporting process
Regulatory support
A professional approach to clinical trials and bioequivalence studies
Our company offers full support in conducting clinical trials and bioequivalence studies, ensuring compliance with the guidelines of the EMA, FDA, ICH-GCP, and GLP.
Thanks to advanced research infrastructure, experience, and strict quality control, we guarantee effective and timely completion of studies.
We help create the solutions of tomorrow