01
01
Badania biorównoważności
Od planowania po raport końcowy
02
02
Badania kliniczne
Fazy I–IV
03
03
Doradztwo regulacyjne
Strategia, dokumentacja, kontakt z urzędami
04
04
Analityka i bioanaliza
Precyzyjna ocena danych
05
05
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.