Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello - what is a good estimate for hiring a consultant to assist with Health Canada and MDEL applications for a Class III medical device? This would include preparation of the SOP 001-005, assisting with labeling advice, and helping out with the Health Canada audit as well as general consultation throughout the process.

Thanks in advance!

Hi, 

We do Health Canada consulting work starting from $150 per hour to $250 per hour based on the type of work. Quality assurance & MDSAP work is on the lower side of the price and clinical evaluation & regulatory writing is on the higher side. 

Please email me for more details and I will be able to assist you. 

Regards,
Kuldeep

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Kuldeep Tyagi
Founder and CEO, Saraca
Expert on EMDR, CER, FDA
www.saracasolutions.com
+1- 901-286-1890
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Original Message:
Sent: 24-Feb-2021 16:37
From: Anonymous Member
Subject: Health Canada application consulting fees

This message was posted by a user wishing to remain anonymous

Hello - what is a good estimate for hiring a consultant to assist with Health Canada and MDEL applications for a Class III medical device? This would include preparation of the SOP 001-005, assisting with labeling advice, and helping out with the Health Canada audit as well as general consultation throughout the process.

Thanks in advance!

Hello Anon,

I am a regulatory consultant specializing in Health Canada related medical device applications.  Please feel free to contact me (sfuresz@tpireg.com) and we can discuss the costs associated with preparing the SOPs and submitting your MDEL application. 

Our business platform is very flexible and we can do as much or as little as you need us to do.  Therefore we can either do everything on your behalf or just review what you have done yourself and provide feedback.  As we work on an hourly rate, the amount will depend on how much time it takes for us to do the work you wish us to do.

Looking forward to chatting further,

Shirley

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Shirley Furesz RAC
Director, Regulatory Affairs Medical Devices
Oakville Canada
+1 519-242-6476
sfuresz@tpireg.com
------------------------------

Original Message:
Sent: 24-Feb-2021 16:37
From: Anonymous Member
Subject: Health Canada application consulting fees

This message was posted by a user wishing to remain anonymous

Hello - what is a good estimate for hiring a consultant to assist with Health Canada and MDEL applications for a Class III medical device? This would include preparation of the SOP 001-005, assisting with labeling advice, and helping out with the Health Canada audit as well as general consultation throughout the process.

Thanks in advance!