Recently, US FDA Inspected BECRO for one more time, and the Outcome of the Inspection was again Positive with No Observations.
The aim of the FDA Inspection was to determine whether the activities and procedures of BECRO complied with 21 CFR Part 320 – Bioavailability and Bioequivalence (BE). In particular, FDA conducted this inspection to ensure that data and information submitted to FDA by BECRO are scientifically valid and reliable and also, to ensure that the rights, welfare, and safety of research subjects are protected during the study of investigational products.
Note that BECRO is one of the very few CROs with No Observations in all FDA Inspections.
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 Pharmacokinetic studies.
- Clinical investigations for Medical Devices.
- Monitoring services.
Also, BECRO specializes in drafting modules of CDT and CERs for Medical Devices, and in preparing CDT and CDISC for US FDA submissions.
BECRO will continue to provide high quality services to our Sponsors.