FDA Warning Letter Response
If this has happened to you, IQCDS warning letter response and remediation services may be right for you. Do not try to respond on your own unless you have extensive expertise in responding to the FDA. IQCDS can help you develop proven responses that will give you time to implement the short and long term remediation and corrective actions the FDA demands. There is a right and a wrong way to respond to FDA warning letters. IQCDS’s FDA regulatory compliance consulting expert will help you formulate the correct response for your situation.
Responding to the FDA is only half the battle. IQCDS will help sort it out and provide you with a clear remediation and corrective action plan for moving forward. IQCDS will not just give you advice but will help you implement the specific actions you need to clear your company of the warning letter quickly. As an added bonus, IQCDS always focuses on creating business value that improves your company’s performance along the way. You get much more than simple compliance.
Any medical device/pharmaceutical company can find themselves staring at a warning letter (or worse). Let IQCDS help today!
Mr. Saldana, President of IQCDS has over 25+ years’ experience and a proven track record to get you out of the FDA spotlight quickly and get you back to your normal business operations. To discuss assistance with warning letter response please contact us at (949) 235-6037 or email us at info@iqcds.com.
International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.