BECRO is participating as Exhibitor at CPhI Milan 2024 (8-10 October), Stand 24D44.
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
- Bioavailability and Bioequivalence 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, and the outcome of the inspections was positive with No Observations. FDA conducted these inspections to “ensure that data and information submitted to FDA by BECRO are scientifically valid and reliable” and to determine whether the activities and procedures of BECRO complied with 21 CFR Part 320 – Bioavailability and Bioequivalence (BE).