Bioequivalence
Designed for EU submission and aligned with the EMA bioequivalence guideline, including fixed-dose combination and statin-based studies, and biowaiver justification for additional strengths based on linear pharmacokinetics and proportional formulations.
What is included
- Regulatory consulting and protocol design
- Ethics and competent authority submissions
- Clinical conduct under fasting conditions
- Bioanalysis at a GLP-certified partner laboratory
- Biostatistics, CSR and an eCTD-ready dossier
- Regulatory fees, site contracts and subject compensation
Our sites
Fully equipped bioequivalence sites in Armenia, Poland and Czechia, available to sponsors as part of a Paspigioni-run study.
Studies delivered
Fentanyl nasal spray, aripiprazole, mometasone furoate with azelastine, and acetylcysteine for acute uncomplicated rhinosinusitis.