Is your company over-spending in regulatory support? Dealing with a 483?
FDA Warning Letters requires immediate and expert attention …they mean that the Agency has found that one or more of your practices, processes, or products are in violation of FDA requirements and the Agency is prepared to take action. Viewed from a different perspective, an FDA Warning Letter provides you the opportunity to take corrective measures to prevent further enforcement actions. A well-crafted, thorough response to a Warning Letter can mean the difference between the issue being resolved, or products being seized and facilities being shut down.
At Lean Enterprise Consulting, we have FDA consultants, experts in the compliance process, who have worked worldwide for many years assisting other clients in obtaining a favorable regulatory status.
We don’t rely on a “Quantum Company Name” and ridiculously expensive consulting fees, we depend on our consultant’s in-depth knowledge of FDA laws and regulations that apply to the life-sciences industry. We rely on the competence of our team members, competence that comes from experience. At Lean Enterprise Consulting we have a lot of that, but we know that experience isn’t everything. Competence also comes from continued research and study of past and current interpretations of the regulations and enforcement.
If you’d like assistance in responding to an FDA Warning Letter, please contact us immediately. Regulatory support does not have to be expensive, do not pay for the company name ….pay for knowledge, engagement with your own company-specific issues and experience.
Lean Enterprise Consulting – United States – Spain – India