GCP Consulting for Young Biotech

Drug Safety Consult offers GCP and QA support to young biotech firms.

GCP consulting within early phase clinical development aims for a slim, robust and transparent setup. Your structure must ensure that any data obtained or documentation created, complies with the GCP requirements and that the “re-do’s” due to poor planning are avoided.

Drug Safety Consult can be a competent consulting partner, assist you in getting critical GCP systes in place internally or via outsourcing, and can offer to audit a potential vendor or CRO and can help your prepare for an authority inspections within GCP and Pharmacovigilance.

It is in any company’s interest to be in control of their development programs, choose the right strategy, focus on what is essential for GCP compliance and have a clear picture of need to have versus nice to have. ...And from the very first step, it is crucial to get this right!

Whether done in house or outsourced, GCP compliance remains the ultimate responsibility of Sponsor!​