510K程序与费用

PROFESSIONAL SERVICE PROPOSAL
BETWEEN
REGULATORY COMPLIANCE SOLUTIONS, LLC
And
HuBei Weil Kang Protective Products Co, LTD
Regulatory Compliance Solutions, LLC (RCS) is pleased to be able to contribute to HuBei Weil Kang Protective Products Co, LTD planned medical device product commercialization efforts and has made a genuine attempt to provide meaningful and realistic cost estimates.
Services:
Regulatory Guidance and Project Management
RCS will provide routine correspondences as to the status of the project via teleconference or email.
1. 510K Review and Advisory Assessment
A) Review existing 510K submission and all FDA correspondences.
i.FDA Interaction – Limit to 1 or 2 calls
1.Identify the next steps.
B) Provide information to client and discuss next steps.
2. Revision of the Present 510K Submission and Interaction with FDA.
A) Prepare revised 510K.
3. Prepare a New 510K Submission and Interaction with FDA.
A) Prepare 510K.
4. FDA Site Readiness Assessment
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A) Evaluate and Prepare Documentation and Instructions to existing client staff for FDA Site
visit or audit.
Timelines: The timelines and hours will be agreed upon by the HuBei Weil Kang Protective Products Co, LTD and RCS and depend on the final submission of data and reports from the HuBei Weil Kang Protective Products Co, LTD and/or the HuBei Weil Kang Protective Products Co, LTD’s contractors. TERMS:
RETAINER FEE: $15,000.00 USD IS REQUIRED PRIOR TO STARTING. Retainer Fee will be applied to balance of due.
PAYMENT; DEFAULT: Payment in full for invoices shall be due within Pre-paid or Net 15 days from invoice date, at Regulatory Compliance Solutions, L.L.C. - 12 Holly Drive – Suite 100 Upper Saddle River, NJ 07458. Invoices that are more than (7) days past due the amount of the past due are subject to a late charge of one percent (3 %) per month on the amount of the past due balance. Late charges shall be calculated using the U.S. Method, therefore interest will not be compounded on the past due balance. If the
Client’s account is past due and REGULATORY COMPLIANCE SOLUTIONS, L.L.C. has notified Client
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verbally or in writing of the past due balance, REGULATORY COMPLIANCE SOLUTIONS, L.L.C. may, without advance notice, immediately cease providing any and all further Contract Employee services without any liability to Client for interruption of pending work.
EXPENSES: Client shall reimburse REGULATORY COMPLIANCE SOLUTIONS, L.L.C. for all ordinary, necessary, and reasonable travel expenses incurred by Contract Employee(s) while performing services on behalf of Client. This estimate is based on the work being completed at Regulatory Compliance Solutions, L.L.C. offices.
COLLECTION:If the Client’s account, after default, is referred to an attorney or col lection agency for collection, Client shall pay all of REGULATORY COMPLIANCE SOLUTIONS, L.L.C. expenses incurred in such collection efforts including, but not limited to, court costs and reasonable attorneys’ fees. Notwithstanding the above and the terms of this Agreement, REGULATORY COMPLIANCE SOLUTIONS, L.L.C. may institute proceedings to seek a default judgment in any court of competent jurisdiction in the United States.
All payments to RCS are pre-paid or Net 15.
Client will give a Retainer Fee of $15,000.00 towards this project. This retainer fee will be for a maximum of 20 hours.
Total Estimated Costs of the Project is: $ 57,000.00 - $75,000 U.S. Dollars Disclaimer:
Regulatory Compliance Solutions, L.L.C. does not in any way or expressed the views of the FDA during the approval process. Regulatory Compliance Solutions, L.L.C. can not in any way guarantee FDA approvals.
Effective Date. The Effective Date of this PROFESSIONAL SERVICES Agreement is May 20, 2011. This proposal is valid for 14 days from today.
IN WITNESS WHEREOF, the parties have so agreed as of the date written above. REGULATORY COMPLIANCE SOLUTIONS, LLC 12 Holly Drive – Suite 100 Upper Saddle River, New Jersey 07458
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Ms. Deborah Cenci
CEO and President
By: Its:
Date: 05/20/2011
Spenser (full name required and address) V.P. Product Development
HuBei Weil Kang Protective Products Co, LTD Address:
Address:
By: Its: ____________________________________ Date:
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