FLEXIBILITY

While many people think that regulatory authority inspections only happen after a Regulatory Application is submitted, the truth is that the Authorities can inspect a biotech/pharma sponsor company at any point during the clinical development lifecycle. Because of this, it is critical that a clinical program have a mindset of being “inspection ready” from the initiation of the very first clinical study.

Ciall specializes in Inspection Readiness support for both GCP inspections as well as GMP Pre-approval Inspections (PAIs), ensuring our clients understand what type of documentation is needed, and helping to collect and organize those artifacts to ensure that our clients are ready at any point in time to answer inspection questions. Our experts have vast experience planning and hosting Regulatory Inspections, and we use that knowledge and experience to support not only the documentation aspect of an Inspection but also Inspection logistics so that every detail is addressed.