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Welcome to Klassen Consulting, LLC
Dedicated to offering realistic and practical advice, based on solid experience and a fundamental knowledge of the U.S. regulatory landscape pertaining to Chemistry, Manufacturing and Controls (CMC) and Regulatory Compliance with current Good Manufacturing Practice (cGMP) for pharmaceutical, biotechnological, and biological sterile injectable drug products.
Active Pharmaceutical Ingredients and Drug Product Submissions:
Lack of adequate information in the CMC section (CTD Module 3) of investigational and license applications submitted to the U.S. FDA constitute the majority of submission failures, delays, and rejections.
We can guide you through this crucial section of investigational and license submissions to mitigate the risk of failures and rejections and minimize the impact of multiple information requests and holds. We can also guide you through the FDA meeting process with training and support towards achieving a successful meeting with the Agency.
Remediation and Prevention:
Lack of adequate Regulatory Compliance of suppliers, manufacturers and distributors can stop a company cold in its tracks and while a good deal may seem to save money in the short term, the long term consequences can cause a company to suffer serious financial and public disgrace and is never a cost savings in the long run. If the consequences are severe enough, fines, closures, even arrests and incarceration may result.
We can assist you in remediation of FDA actions and determination of compliance risk and prevention to avoid or mitigate potential regulatory actions such as 483s, warning or untitled letters, or consent decrees.