BECRO is participating as Exhibitor in CPhI Frankfurt 2025 (October 28-30), Stand 9.2C82.
BECRO is specialized in the conduct of Therapeutic Equivalent (Non-Inferiority) studies (Bioequivalence studies with Clinical End-points) for Topical Generic products:
- Ophthalmic (leading CRO in Europe),
- Inhalers,
- Dermatological,
- Anesthetics and NSAIDs,
- Suppositories,
- Nasal
- Otic
Bioequivalence-Pharmacokinetic studies.
Superiority studies for Generic products.
Clinical investigations for Medical Devices.
BECRO offers clinical trials services all the way from study set up to submission.
In addition, BECRO specializes in drafting modules of CDT and CERs for Medical Devices, and in preparing CDT and CDISC for US FDA submissions. BECRO has been inspected by US FDA twice for data integrity and compliance with 21 CFR Part 320 – Bioavailability and Bioequivalence (BE), and the outcome of the inspections was positive with No Observations. Also, FDA has inspected Clinical Facilities where BECRO conducts Therapeutic Equivalent studies (especially, studies for Inhalers). No Form-483 was issued.