Validate My Processes
What You Are Dealing With
Your validation program has gaps and you know it. Processes, equipment, or cleaning procedures that were never formally validated, or were validated years ago under standards that no longer reflect current FDA expectations, create exposure every time an investigator walks through the door. Validation gaps also surface during scale-up, technology transfer, and new product introduction, exactly when you can least afford a delay. You need a team that can assess where you stand, close the gaps efficiently, and produce documentation that holds up to regulatory scrutiny.
How We Approach It
We assess your current validation state against FDA requirements and applicable guidance, identify the gaps that carry the most risk, and design and execute the validation work needed to close them. We cover process validation, cleaning validation, equipment qualification, and continued process verification, using a risk-based approach that focuses resources on what matters most.
What We Have Done
A biopharmaceutical company developing novel therapies engaged MEDVACON to lead process validation at their contract manufacturer. MEDVACON reviewed validation protocols and oversaw the entire validation process to ensure compliance. The product received FDA approval and MEDVACON remains a trusted partner providing ongoing CMC and clinical supply support.
A contract manufacturer engaged MEDVACON to troubleshoot an aseptic pharmaceutical process producing unwanted particulates. MEDVACON identified the process defect onsite, developed a technical report with a solution, and implemented the fix. Production resumed and costly rejected batches and production delays were eliminated.